| 13 Jul 2026 | Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL | Device | Class II | 2 | Ongoing |
| 6 Jul 2026 | Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic | Device | Class II | 1 | Ongoing |
| 26 Jun 2026 | Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL | Device | Class III | 1 | Ongoing |
| 26 Jun 2026 | Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL | Device | Class III | 1 | Ongoing |
| 8 Jun 2026 | Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536. | Device | Class II | 1 | Ongoing |
| 7 May 2026 | Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay | Device | Class II | 1 | Ongoing |
| 2 Apr 2026 | epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; | Device | Class II | 1 | Ongoing |
| 18 Mar 2026 | Dimension Creatinine Flex reagent cartridge. Material Number: 10872079. | Device | Class II | 1 | Ongoing |
| 23 Feb 2026 | Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536; | Device | Class II | 1 | Ongoing |
| 20 Jan 2026 | Atellica CH Urine Albumin (UAlb). Material Number: 11537225 | Device | Class II | 1 | Ongoing |
| 6 Oct 2025 | IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6; | Device | Class II | 3 | Ongoing |
| 22 Sep 2025 | Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6; | Device | Class II | 1 | Ongoing |
| 11 Aug 2025 | Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543. | Device | Class II | 1 | Ongoing |
| 7 Jul 2025 | epoc BGEM BUN Test Card [25pk]. Material Number: 10736515. | Device | Class II | 1 | Ongoing |
| 26 Jun 2025 | RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097. | Device | Class II | 1 | Ongoing |
| 4 Jun 2025 | ADVIA 120/2120/2120i SETpoint Calibrator | Device | Class II | 4 | Ongoing |
| 22 May 2025 | Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300; | Device | Class II | 1 | Ongoing |
| 15 Apr 2025 | Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498 | Device | Class II | 2 | Ongoing |
| 31 Mar 2025 | Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma. | Device | Class II | 1 | Ongoing |
| 19 Mar 2025 | epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n. | Device | Class II | 2 | Ongoing |
| 11 Mar 2025 | Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223. | Device | Class II | 1 | Ongoing |
| 22 Nov 2024 | epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at… | Device | Class II | 8 | Ongoing |
| 12 Nov 2024 | Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158; | Device | Class II | 1 | Ongoing |
| 4 Nov 2024 | Atellica CI Analyzer. Catalog Numbers: 10947347. | Device | Class II | 1 | Ongoing |
| 21 Oct 2024 | Atellica CH 2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of 2-microglobulin in human serum and plasma. Siemens Material Number (SMN): 11097635 | Device | Class II | 1 | Ongoing |
| 21 Oct 2024 | Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step. Siemens Material Number(SMN): 11099326 All lots starting with N15 or 15 are expected to have the defect. | Device | Class II | 1 | Ongoing |
| 30 Sep 2024 | IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282) | Device | Class II | 1 | Ongoing |
| 24 Sep 2024 | epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515 | Device | Class II | 1 | Ongoing |
| 21 Aug 2024 | ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test) | Device | Class II | 2 | Ongoing |
| 15 Aug 2024 | Atellica CH Microalbumin_2 (ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers | Device | Class II | 2 | Ongoing |
| 30 Jul 2024 | Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146; | Device | Class II | 1 | Ongoing |
| 29 Jul 2024 | Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543 | Device | Class II | 2 | Ongoing |
| 26 Jul 2024 | Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10995490 | Device | Class II | 5 | Ongoing |
| 17 May 2024 | Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China) 11416752; RAPIDPoint 500e Blood Gas System (Japan) 11416754; RAPIDPoint 500e Blood Gas System (ROW) 11416755 ; | Device | Class II | 1 | Ongoing |
| 23 Apr 2024 | IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody. | Device | Class II | 2 | Ongoing |
| 13 Mar 2024 | Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium heparin) using the Atellica CI Analyzer and Atellica CH Analyzer Siemens Material Number (SMN): 11537211 | Device | Class II | 1 | Ongoing |
| 7 Feb 2024 | DCA Systems HbA1c Reagent Kit | Device | Class II | 1 | Ongoing |
| 24 Jan 2024 | Atellica IM Erythropoietin (EPO) Assay (100 Test) | Device | Class II | 2 | Ongoing |
| 15 Dec 2023 | Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry | Device | Class II | 1 | Ongoing |
| 26 Oct 2023 | RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10844813 | Device | Class II | 4 | Ongoing |
| 19 Oct 2023 | epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4 to the current version 4.11.11 | Device | Class II | 1 | Ongoing |
| 26 Sep 2023 | RAPIDPOINT 500e Blood Gas System | Device | Class II | 2 | Ongoing |
| 8 Aug 2023 | ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests) | Device | Class II | 1 | Ongoing |
| 25 Jul 2023 | ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the quantitative determination of total protein in human urine and cerebrospinal fluid | Device | Class II | 1 | Ongoing |
| 10 Jul 2023 | Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test Code: TBil_2 Siemens Material Number (SMN): 11097531 | Device | Class II | 4 | Ongoing |
| 1 Jun 2023 | epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1 | Device | Class II | 3 | Ongoing |
| 16 May 2023 | Aptio Automation Storage and Retrieval Module (SRM) | Device | Class II | 1 | Ongoing |
| 5 Apr 2023 | ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acetaminophen (ACET), and salicylate (SAL) assays on the ADVIA Chemistry systems Siemens Material Number (SMN): 10309217 | Device | Class II | 2 | Ongoing |
| 16 Mar 2023 | Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and lithium heparin), and urine. | Device | Class II | 2 | Ongoing |
| 30 Jan 2023 | Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension clinical chemistry system SMN: 10700795 (DF207) | Device | Class II | 1 | Ongoing |
| 27 Jan 2023 | Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097632 | Device | Class II | 4 | Ongoing |
| 9 Jan 2023 | Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995572 | Device | Class II | 6 | Ongoing |
| 22 Dec 2022 | ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative detection of antibodies to the e antigen of the hepatitis B virus (HBV) in human pediatric (2-21 years old) and adult serum, EDTA plasma, or lithium heparin. Siemens Material Number (SMN): 10720831 | Device | Class II | 1 | Ongoing |
| 12 Dec 2022 | epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished 10736393 epoc Host 2, Canada, Refurbished 10736394 epoc Host 2, Japanese, Refurbished 10736395 epoc Host 2, Chinese, Refurbished 10736433 epoc Host 2, US… | Device | Class II | 2 | Ongoing |
| 7 Dec 2022 | IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi) for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroidectomy. Catalog # L2KTY2(D) Siemens… | Device | Class II | 2 | Ongoing |
| 4 Nov 2022 | IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Material Number (SMN): 10708840 For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated… | Device | Class II | 3 | Ongoing |
| 25 Oct 2022 | IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers for the quantitative measurement of total testosterone in serum and heparinized plasma. | Device | Class II | 1 | Ongoing |
| 19 Sep 2022 | Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay | Device | Class II | 2 | Ongoing |
| 30 Aug 2022 | N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297 | Device | Class II | 2 | Ongoing |
| 24 Aug 2022 | Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A | Device | Class II | 1 | Ongoing |
| 17 Aug 2022 | Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57 | Device | Class II | 1 | Ongoing |
| 11 Aug 2022 | IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN): 10876421 US; 10713448 (OUS) | Device | Class II | 1 | Ongoing |
| 18 Jul 2022 | Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456 | Device | Class II | 1 | Ongoing |
| 28 Jun 2022 | Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples. | Device | Class II | 1 | Ongoing |
| 1 Jun 2022 | epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood Product Siemens SMN#/Model #: 10736515 | Device | Class II | 1 | Ongoing |
| 18 May 2022 | Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444896/RF521 | Device | Class II | 2 | Terminated |
| 13 Apr 2022 | Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001 | Device | Class II | 2 | Ongoing |
| 3 Mar 2022 | Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots | Device | Class II | 6 | Ongoing |
| 22 Feb 2022 | IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6] | Device | Class II | 1 | Ongoing |
| 9 Feb 2022 | Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644 | Device | Class II | 4 | Ongoing |
| 28 Jan 2022 | Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System. The Dimension Vista Magnesium Flex Reagent (MG) method is an In vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma, and urine on the Dimension… | Device | Class II | 1 | Ongoing |
| 1 Dec 2021 | Atellica CH 2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of 2-microglobulin in human serum and plasma Siemens Material Number (SMN): 11097635 | Device | Class II | 1 | Terminated |
| 18 Nov 2021 | Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000 | Device | Class II | 1 | Ongoing |
| 15 Oct 2021 | Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10444801(US) and 10444802 (OUS) | Device | Class II | 2 | Terminated |
| 6 Oct 2021 | Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038 | Device | Class II | 1 | Ongoing |
| 28 Sep 2021 | Atellica IM 1300 Analyzer, SMN 11066001 | Device | Class II | 2 | Ongoing |
| 22 Sep 2021 | Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861 | Device | Class II | 2 | Terminated |
| 20 Sep 2021 | Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543 | Device | Class II | 2 | Ongoing |
| 6 Jul 2021 | Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995478 | Device | Class II | 3 | Ongoing |
| 18 May 2021 | The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes. Tests performed using this system are intended for in vitro diagnostic use. | Device | Class II | 1 | Terminated |
| 13 May 2021 | Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000 | Device | Class II | 3 | Ongoing |
| 4 May 2021 | Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000 | Device | Class II | 1 | Ongoing |
| 21 Apr 2021 | Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to Treponema pallidum in human serum or plasma using the ADVIA Centaur XP/XPT System and ADVIA Centaur CP Systems, SMN:10492493 | Device | Class II | 1 | Ongoing |
| 5 Mar 2021 | ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 and 6.11 | Device | Class II | 20 | Ongoing |
| 2 Mar 2021 | BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulation System is an instrument intended to perform quantitative assays of a specific parameters in plasma. | Device | Class II | 1 | Terminated |
| 8 Feb 2021 | Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2 | Device | Class II | 1 | Terminated |
| 3 Feb 2021 | Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases, and in the assessment of risk for atherosclerosis and cardiovascular disease. | Device | Class II | 1 | Ongoing |
| 2 Dec 2020 | Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode… | Device | Class II | 3 | Terminated |
| 23 Nov 2020 | ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): ADVIA Chemistry: 10309495 (20 mL) 10316298 (70 mL) | Device | Class II | 2 | Ongoing |
| 26 Oct 2020 | Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001 | Device | Class II | 2 | Terminated |
| 22 Sep 2020 | ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941 | Device | Class II | 2 | Ongoing |
| 28 Aug 2020 | Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care SMN#/Model #: 10736382 | Device | Class II | 1 | Terminated |
| 25 Aug 2020 | Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)20210130 and (01)00630414599151(10)32478139(17)20210130 Atellica IM HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10995592, UDI Code (01)00630414599168(10)22695A49(17)20201211 ADVIA Centaur… | Device | Class II | 1 | Terminated |
| 25 Aug 2020 | Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma Catalog Number: K2115, SMN# 10642444 | Device | Class II | 1 | Terminated |
| 19 Aug 2020 | Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number: RF627, SMN# 10471068 | Device | Class II | 1 | Terminated |
| 24 Jul 2020 | Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number K6427, SMN# 104471067 | Device | Class II | 1 | Terminated |
| 30 Jun 2020 | DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US | Device | Class II | 1 | Terminated |
| 5 Jun 2020 | ADVIA Chemistry Calibrator | Device | Class II | 2 | Terminated |
| 27 May 2020 | RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778 | Device | Class II | 1 | Terminated |
| 15 May 2020 | Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use in a laboratory environment only. | Device | Class II | 2 | Terminated |
| 15 May 2020 | (1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System software version 16.0.3 Siemens Material Number (SMN): 11314337 Product Usage: are clinical laboratory information modules which consolidate test orders and test results, provide… | Device | Class II | 2 | Terminated |
| 7 May 2020 | Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960 | Device | Class II | 2 | Ongoing |
| 4 May 2020 | ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage: use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma for monitoring the blood glucose levels of diabetic patients over the preceding two-three weeks. | Device | Class II | 6 | Terminated |
| 27 Feb 2020 | Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower | Device | Class II | 1 | Terminated |
| 14 Feb 2020 | Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use. | Device | Class II | 1 | Terminated |
| 13 Feb 2020 | Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA Chemistry systems. Such measurements are useful… | Device | Class II | 6 | Terminated |
| 5 Feb 2020 | IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in vitro diagnostic use with the IMMULITE systems Analyzers for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various sexual disorders. | Device | Class II | 2 | Terminated |
| 12 Jan 2020 | Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143 | Device | Class II | 1 | Ongoing |
| 6 Jan 2020 | Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage: The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology… | Device | Class II | 2 | Terminated |
| 20 Dec 2019 | ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 00630414482446 - Product Usage: Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas, such as acute pancreatitis and obstruction of the pancreatic duct. | Device | Class II | 1 | Terminated |
| 18 Dec 2019 | ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869 | Device | Class II | 4 | Terminated |
| 19 Nov 2019 | ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - product Usage: For in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the CardioPhase hsCRP assay. | Device | Class II | 2 | Terminated |
| 11 Oct 2019 | Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930 Analyzer is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. | Device | Class II | 1 | Terminated |
| 23 Sep 2019 | Atellica CH 930 Analyzer | Device | Class II | 1 | Terminated |
| 15 Aug 2019 | Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001 | Device | Class II | 2 | Terminated |
| 14 Aug 2019 | Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 - Product Usage: The ADVIA Centaur Anti-CCP IgG (aCCP) assay is for in vitro diagnostic use in the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in… | Device | Class II | 1 | Terminated |
| 30 Jul 2019 | Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens | Device | Class II | 1 | Terminated |
| 22 Jul 2019 | Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308 | Device | Class II | 3 | Terminated |
| 15 Jul 2019 | Dimension Ferritin (FERR) Flex reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dimension RxL clinical chemistry system to quantitatively measure ferritin in human serum and plasma. Measurements of ferritin aid in the diagnosis of diseases affecting iron… | Device | Class II | 1 | Terminated |
| 10 Jul 2019 | IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128 | Device | Class II | 2 | Terminated |
| 27 Jun 2019 | N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material Number (SMN):10446539 | Device | Class II | 1 | Terminated |
| 29 May 2019 | Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI). | Device | Class II | 1 | Terminated |
| 3 May 2019 | ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA… | Device | Class II | 2 | Terminated |
| 7 Mar 2019 | Atellica IM 1300 Analyzer, Material Number 11066001 | Device | Class II | 3 | Terminated |
| 12 Dec 2018 | Dimension Vista 500, Analyzer, chemistry Model no. 10284473 | Device | Class II | 2 | Terminated |
| 7 Dec 2018 | Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398 | Device | Class II | 4 | Terminated |
| 16 Oct 2018 | Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. | Device | Class II | 2 | Terminated |
| 11 Oct 2018 | Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in human serum and plasma on the Dimension Vista System.Cat. No. K2054, Mat. No. 10464323 | Device | Class II | 1 | Terminated |
| 28 Sep 2018 | Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number: Dimension EXL 200 00630414593579; Dimension EXL with LM 00630414593500; Dimension EXL with LM with STM 00630414593593; Dimension RxL Max 00630414949789; Dimension RxL Max HM 00630414949796; Dimension RxL Max HM STM… | Device | Class II | 1 | Terminated |
| 26 Sep 2018 | Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various… | Device | Class II | 4 | Terminated |
| 7 Sep 2018 | Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension clinical chemistry system. | Device | Class II | 2 | Terminated |
| 14 Aug 2018 | APTIO INPUT/OUTPUT MODULE | Device | Class II | 9 | Terminated |
| 24 Jul 2018 | ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays. | Device | Class II | 5 | Terminated |
| 16 Jul 2018 | RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, hematocrit, neonatal total… | Device | Class II | 4 | Terminated |
| 29 Jun 2018 | Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. | Device | Class II | 6 | Terminated |
| 19 Apr 2018 | Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275. | Device | Class II | 2 | Terminated |
| 27 Mar 2018 | ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems | Device | Class II | 1 | Terminated |
| 21 Mar 2018 | Dimension Vista CTNI Sample Diluent, KD692, SMN# 10445205 | Device | Class II | 3 | Terminated |
| 12 Mar 2018 | Syva EMIT II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483 | Device | Class III | 2 | Terminated |
| 26 Feb 2018 | Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens. | Device | Class II | 3 | Terminated |
| 21 Feb 2018 | ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests) | Device | Class II | 1 | Terminated |
| 30 Jan 2018 | Dimension Vista Calcium Flex reagent cartridge, Dimension Vista CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plasma, and urine on the Dimension Vista System. | Device | Class II | 1 | Terminated |
| 2 Jan 2018 | Dimension Thyroid Stimulating Hormone (TSHL) Flex reagent cartridge | Device | Class II | 24 | Terminated |
| 18 Dec 2017 | ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests), 02816634 (500 tests) | Device | Class II | 2 | Ongoing |
| 14 Dec 2017 | Dimension Lipase Flex Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase) | Device | Class II | 1 | Terminated |
| 27 Nov 2017 | Syva EMIT 2000 Theophylline Product Usage: The Syva Emit 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma. | Device | Class II | 1 | Terminated |
| 9 Nov 2017 | Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), and estradiol (E2) methods on the Dimension Vista System. | Device | Class II | 1 | Terminated |
| 28 Jul 2017 | ADVIA Centaur T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of triiodothyronine (T3) in serum using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. Measurements of triiodothyronine are used in the diagnosis and treatment of thyroid disease. | Device | Class II | 1 | Terminated |
| 29 Jun 2017 | ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA). Product Number: 10286035 (Mfr: Randox Laboratories) | Device | Class II | 17 | Terminated |
| 7 Jun 2017 | ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756. | Device | Class II | 1 | Terminated |
| 23 May 2017 | Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Product Code KC710U (US) and KC710 (OUS); IVD | Device | Class II | 4 | Terminated |
| 10 Apr 2017 | RAPIDPoint 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. Siemens SMN numbers: 10492730,… | Device | Class II | 1 | Terminated |
| 5 Apr 2017 | ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899 | Device | Class II | 2 | Terminated |
| 21 Mar 2017 | Dimension Troponin 1 (TNI) Flex reagent cartridge | Device | Class II | 6 | Terminated |
| 8 Mar 2017 | Siemens ADVIA Centaur BR assay Cat No. 02419937, SMN 10333349 (1-pack/50 tests) BR Assay for CA 27.29 The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT… | Device | Class II | 3 | Terminated |
| 3 Mar 2017 | Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer, chemistry (photometric, discrete), for clinical use Product Usage: The Siemens Healthcare Diagnostics Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as… | Device | Class II | 1 | Terminated |
| 23 Feb 2017 | ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, ALTP5P, ALTP_c, ASTP5P and ASTP_c | Device | Class III | 1 | Terminated |
| 2 Feb 2017 | ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. The ADVIA Centaur XPT System is a stand-alone, continuous operation, immunochemistry analyzer that performs the following functions: aspirates and dispenses samples; Performs dilutions; Adds reagents; Incubates reaction vessels;… | Device | Class II | 1 | Terminated |
| 31 Jan 2017 | SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the quantitative measurement of SHBG in serum, as aid in the differential diagnosis of hirsutism. | Device | Class II | 1 | Terminated |
| 11 Jan 2017 | N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with BN II and BN ProSpec System. The device can… | Device | Class II | 1 | Terminated |
| 10 Jan 2017 | Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF) | Device | Class II | 3 | Terminated |
| 4 Jan 2017 | ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test for the quantitative measurement of progesterone in human serum and plasma on the Dimension Vista System. Progesterone measurements are used in the diagnosis and treatment of disorders… | Device | Class II | 4 | Terminated |
| 21 Dec 2016 | IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of… | Device | Class II | 2 | Terminated |
| 16 Dec 2016 | Dimension Ammonia Flex reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension clinical chemistry system. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis,… | Device | Class II | 2 | Terminated |
| 29 Nov 2016 | CentraLink Data Management System Software Versions: v13x,v14x,v15x The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an… | Device | Class II | 1 | Terminated |
| 22 Nov 2016 | SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) Test Code iPTH, REF/Catalog Number L2KPP2, Siemens Material Number (SMN) 10381441 and REF/Catalog Number L2KPP6, SMN 10381442; IVD --- Made in UK -- Siemens healthcare Diagnostics Products Ltd. Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL UK For in… | Device | Class II | 1 | Terminated |
| 18 Nov 2016 | IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (US); Catalog Number LKPS1, SMN 10380960 and Catalog Number LKPS5, SMN 10380949 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL554EL UK… | Device | Class II | 2 | Terminated |
| 21 Oct 2016 | ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD. | Device | Class II | 1 | Terminated |
| 19 Oct 2016 | ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491379 In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT instrument. Siemens stated that the assay is… | Device | Class II | 2 | Terminated |
| 7 Oct 2016 | Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the following methods: Albumin (ALB, ALB_c), Direct Bilirubin (DBIL_2), Total Bilirubin (TBIL_2), Calcium (CA, CA_c, CA_2, CA_2c), Cholesterol (CHOL), Creatinine (CREA, CREA_2, CRE_2c, ECRE_2), Glucose Hexakinase… | Device | Class II | 1 | Terminated |
| 5 Oct 2016 | Siemens ADVIA Centaur Vitamin D Total Assay SMN 10699201 (100 test) | Device | Class II | 2 | Terminated |
| 29 Sep 2016 | Aptio Automation Modules | Device | Class II | 2 | Terminated |
| 15 Sep 2016 | Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA/CRE2), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid… | Device | Class II | 1 | Terminated |
| 2 Sep 2016 | Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161 | Device | Class III | 2 | Terminated |
| 30 Aug 2016 | IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (US), Unique Device Identification Number (UDI) 00630414985718 (US); and REF/Catalog Number LKCM1 - 100 tests (OUS); SMN 10381296 (OUS), UDI 00630414963747 (OUS); IVD --- Made in UK… | Device | Class II | 2 | Terminated |
| 25 Aug 2016 | Dimension Vista IRON Flex reagent cartridges | Device | Class III | 2 | Terminated |
| 24 Aug 2016 | SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for… | Device | Class II | 2 | Terminated |
| 11 Aug 2016 | Siemens RAPIDPoint 400 Blood Gas Analyzer Siemens Material Number (SMN): 10291507,10314585, 10318899,10321239,10322654,10324081, 10328803, 10331381, 10339634 | Device | Class II | 7 | Terminated |
| 9 Aug 2016 | ADVIA Centaur PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test) | Device | Class II | 1 | Terminated |
| 8 Aug 2016 | Siemens ADVIA Centaur Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglobin cTnl Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 (SMN 1 0309996) | Device | Class II | 1 | Terminated |
| 3 Aug 2016 | Dimension Vista Calcium (CA) Flex reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB | Device | Class II | 1 | Terminated |
| 20 Jul 2016 | ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when HbA1c values are reported in International Federation of Clinical Chemistry (IFCC) equivalent units (HbA1cR). The ADVIA Chemistry XPT System is an automated, clinical… | Device | Class II | 1 | Terminated |
| 5 Jul 2016 | Siemens RAPIDPoint 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use in a point-of care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous,… | Device | Class III | 1 | Terminated |
| 22 Jun 2016 | Stratus CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB, cTNI, D-Dimer, Myoglobin, and pBNP. SMN: 10444834, 10453531 | Device | Class II | 1 | Terminated |
| 17 Jun 2016 | Syva EMIT 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma. | Device | Class II | 2 | Terminated |
| 26 May 2016 | ADVIA Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979). Product Usage: This system is intended for professional use in a laboratory environment only. Tests performed using… | Device | Class II | 1 | Terminated |
| 11 May 2016 | Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836) Aptio Centrifuge Module (10703032 or 10713761) FlexLab High Throughput Centrifuge Module (11171747) FlexLab and Aptio Centrifuge Module (10628157 or 11266581): Used to separate substances according to their densities. | Device | Class II | 1 | Terminated |
| 5 May 2016 | The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Aminotransferase (AST) methods on the Dimension Vista System. For prescription use only. | Device | Class III | 2 | Terminated |
| 2 May 2016 | Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determination of cardiac troponin For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur… | Device | Class II | 1 | Terminated |
| 28 Apr 2016 | ADVIA Centaur XPT Immunoassay System | Device | Class II | 1 | Terminated |
| 15 Apr 2016 | IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma. | Device | Class II | 1 | Terminated |
| 30 Mar 2016 | ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. | Device | Class III | 1 | Terminated |
| 24 Mar 2016 | Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and… | Device | Class II | 2 | Terminated |
| 17 Mar 2016 | Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol | Device | Class II | 16 | Terminated |
| 10 Mar 2016 | ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system for in vitro diagnostic use in clinical laboratories | Device | Class II | 1 | Terminated |
| 8 Mar 2016 | Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of methotrexate in human serum or plasma. | Device | Class II | 1 | Terminated |
| 7 Mar 2016 | ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575. For in vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma on ADVIA Chemistry systems. | Device | Class II | 1 | Terminated |
| 16 Feb 2016 | Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of nitrogen metabolism) in human serum, plasma, and urine on the Dimension Vista System. | Device | Class II | 1 | Terminated |
| 9 Feb 2016 | Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO method is an in vitro diagnostic test for the quantitative measurement of sirolimus in whole blood on the Dimension clinical chemistry system. | Device | Class II | 1 | Terminated |
| 4 Feb 2016 | Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog Number: 04634452 SMN: 10309079 ADVIA Centaur Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone. ADVIA Centaur Testosterone For in vitro diagnostic… | Device | Class II | 3 | Terminated |
| 14 Jan 2016 | BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10454728 (BCS RECONDITIONED), 10454729 (BCS RECONDITIONED), 10454742 (BEHRING COAGULATION SYSTEM), 10459303 (BCS RECONDITIONED), 10460659 (BCS INSTRUMENT), 10461881 (BCS INSTRUMENT), IVD --- Device… | Device | Class II | 2 | Terminated |
| 13 Jan 2016 | Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage: For in vitro diagnostic use in the quantitative determination of estradiol in human serum and plasma (heparinized and EDTA) using the ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur… | Device | Class II | 4 | Terminated |
| 29 Dec 2015 | ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293 (500 test kit) Product Usage: This in vitro diagnostic assay is intended to quantitatively measure prostate-specific Antigen (PSA) in human serum using the ADVIA Centaur/XP/XPT/CP Systems. | Device | Class II | 1 | Terminated |
| 19 Nov 2015 | Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and Quantitative Factor Deficiency | Device | Class II | 1 | Terminated |
| 11 Nov 2015 | Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma Catalog Number: CCTNI SMN: 10445071 | Device | Class II | 11 | Terminated |
| 10 Nov 2015 | Reagent Management System (RMS) Dimension EXL with LM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension clinical chemistry system. The RMS doubles the available storage of refrigerated Flex reagent cartridges on the Dimension system from 44 to 88. The RMS loads, hydrates,… | Device | Class II | 4 | Terminated |
| 3 Nov 2015 | Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Catalog #K7024 SMN: 10445889 Lot #15246MA Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B2-microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension… | Device | Class II | 1 | Terminated |
| 7 Oct 2015 | ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput rate of both 1800 photometric tests per hour and 600 electrolyte (ISE) tests per hour. | Device | Class II | 1 | Terminated |
| 30 Sep 2015 | Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista System. | Device | Class II | 1 | Terminated |
| 24 Sep 2015 | ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems. For in vitro diagnostic use in the quantitative determination of Hemoglobin A1c, a diabetes marker, in whole blood on the ADVIA Chemistry systems. | Device | Class II | 1 | Terminated |
| 28 Aug 2015 | ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. An automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes. | Device | Class II | 1 | Terminated |
| 26 Aug 2015 | syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analytic and post-analytic functions. It works in conjunction with multiple instruments, the laboratory information system (LIS) and the Siemens Healthcare Diagnostics Data… | Device | Class II | 1 | Terminated |
| 24 Aug 2015 | Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number: 10491449 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in… | Device | Class II | 4 | Terminated |
| 28 Jul 2015 | RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, 10696855, 10696857, 10697306 This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. | Device | Class II | 1 | Terminated |
| 27 Jul 2015 | ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay. | Device | Class II | 1 | Terminated |
| 23 Jul 2015 | Dimension Vista B2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B2-Microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of B2-Microglobulin aid in the… | Device | Class II | 1 | Terminated |
| 15 Jul 2015 | Dimension CREA (Creatinine) and Dimension Vista CREA (Creatinine); The CREA method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of creatinine in human serum, plasma and urine. | Device | Class II | 1 | Terminated |
| 30 Jun 2015 | ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lithium heparin) on ADVIA Chemistry systems. | Device | Class II | 1 | Terminated |
| 21 May 2015 | Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer. | Device | Class II | 1 | Terminated |
| 19 May 2015 | ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT/ADVIA Centaur CP… | Device | Class II | 1 | Terminated |
| 19 May 2015 | CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control… | Device | Class II | 1 | Terminated |
| 11 May 2015 | Factor deficient plasma for the Siemens BCS / BCS XP System. In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulometric methods. | Device | Class II | 1 | Terminated |
| 6 May 2015 | The Rapidlab 1260 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood samples. | Device | Class II | 2 | Terminated |
| 6 May 2015 | IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of… | Device | Class II | 1 | Terminated |
| 29 Apr 2015 | EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, the laboratory information system (LIS) and Siemens StreamLAB Automation Solutions. | Device | Class II | 1 | Terminated |
| 20 Apr 2015 | Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone in human serum and plasma on the Dimension Vista System. | Device | Class II | 1 | Terminated |
| 9 Apr 2015 | IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin (TBG) in serum, as an aid in the diagnosis and treatment of thyroid diseases. | Device | Class II | 1 | Terminated |
| 2 Apr 2015 | Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dimension Xpand, Dimension Xpand HM, Dimension Xpand Plus, Dimension Xpand Plus HM. The Dimension EXL clinical chemistry system is a discrete, random-access, microprocessor-controlled, integrated… | Device | Class II | 1 | Terminated |
| 25 Mar 2015 | Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determination of the activated partial thromboplastin time (APTT) and other coagulation procedures requiring an activated partial thromboplastin reagent. | Device | Class II | 1 | Terminated |
| 23 Mar 2015 | ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894. | Device | Class II | 1 | Terminated |
| 24 Feb 2015 | QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical chemistry systems with the QuikLYTE module. Intended Use of the QuikLYTE module : The Na+, K+, Cl and TCO2 methods on the Dimension clinical chemistry system with the QuikLYTE module are in vitro diagnostic tests intended… | Device | Class II | 1 | Terminated |
| 11 Feb 2015 | ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493, IVD. The ADVIA XPT Chemistry System is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput… | Device | Class II | 1 | Terminated |
| 27 Jan 2015 | ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number: 02382928; SMN: 10310305. | Device | Class II | 3 | Terminated |
| 22 Jan 2015 | Siemens Healthcare Caps for capillary 100 uL , Package count 200 For use with blood collection Multicap glass and Multicap-S plastic capillaries SMN: 10311053 Legacy Part number: 478601 | Device | Class II | 3 | Terminated |
| 19 Jan 2015 | ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenobarbital_2 (PHNB_2), Phenytoin_2 (PHNY_2), and Theophylline_2 (THEO_2) methods on the ADVIA Chemistry systems. System Information: (For Information Only) The ADVIA Chemistry systems are automated, clinical chemistry… | Device | Class II | 1 | Terminated |
| 15 Jan 2015 | N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particle-enhanced immunonephelometry using the BN II and BN ProSpec Systems. The determination of IgM aids in the evaluation of the patient's immune system. | Device | Class III | 1 | Terminated |
| 30 Dec 2014 | RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 10322347, 10314817, 10317193, 10318999, 10320055, 10322347, 10328278, 10328302, 10336784. These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in… | Device | Class II | 4 | Terminated |
| 16 Dec 2014 | ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all… | Device | Class II | 1 | Terminated |
| 24 Nov 2014 | Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) method on the Dimension Vista System. | Device | Class II | 1 | Terminated |
| 5 Nov 2014 | Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. | Device | Class II | 1 | Terminated |
| 27 Oct 2014 | Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI). | Device | Class II | 1 | Terminated |
| 20 Oct 2014 | IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi) For in vitro diagnostic use with IMMULITE Systems Analyzers — for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum or heparinized plasma, as an aid in the diagnosis and treatment of diseases… | Device | Class III | 1 | Terminated |
| 17 Oct 2014 | Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli. | Device | Class I | 2 | Terminated |
| 9 Oct 2014 | ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro diagnostic tests. | Device | Class II | 2 | Terminated |
| 6 Oct 2014 | ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: Cat No. 02816138/SMN 10309044 (100 test) 02816634/SMN 10309045 (500 test) | Device | Class III | 1 | Terminated |
| 30 Sep 2014 | Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are… | Device | Class II | 1 | Terminated |
| 26 Sep 2014 | Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref) | Device | Class II | 1 | Terminated |
| 24 Sep 2014 | siemens Dimension Phenytoin Flex Reagent Cartridge The PTN method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended to measure phenytoin (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma. PTN test results are used in the diagnosis and treatment… | Device | Class II | 1 | Terminated |
| 19 Sep 2014 | External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer. | Device | Class II | 3 | Terminated |
| 15 Sep 2014 | Siemens ADVIA Centaur Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc… | Device | Class II | 2 | Terminated |
| 12 Sep 2014 | ADVIA Centaur and ADVIA Centaur XP and ADVIA Centaur CP Cleaning Solution (For in vitro diagnostic use with the ADVIA Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041 The Cleaning Solution is a component of the ADVIA Centaur and ADVIA Centaur XP and ADVIA Centaur CP instruments,… | Device | Class III | 1 | Terminated |
| 28 Aug 2014 | Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System. | Device | Class II | 1 | Terminated |
| 19 Aug 2014 | Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. | Device | Class II | 1 | Terminated |
| 18 Aug 2014 | Siemens Dimension Vista CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (UA) methods on… | Device | Class II | 1 | Terminated |
| 14 Aug 2014 | Dimension Vista HbA1c | Device | Class II | 1 | Terminated |
| 16 Jul 2014 | Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338. | Device | Class II | 1 | Terminated |
| 15 Jul 2014 | Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens Dimension RxL and Xpand assays. The wash buffer is used to clean the probe sensor between uses and prepares it for taking the next reading/measurement. | Device | Class II | 1 | Terminated |
| 23 Jun 2014 | SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System. | Device | Class II | 2 | Terminated |
| 9 Jun 2014 | Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics | Device | Class II | 1 | Terminated |
| 2 Jun 2014 | Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778 Kit Catalog Number: 112219 SMN: 10310026 Intended Use: In vitro diagnostic use. Acid Regent is a component of the ADVIA Centaur and ADVIA Centaur XP instruments | Device | Class II | 1 | Terminated |
| 2 Jun 2014 | MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic | Device | Class II | 1 | Terminated |
| 30 May 2014 | ADVIA Centaur Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790 | Device | Class II | 1 | Terminated |
| 27 May 2014 | Dimension Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids. | Device | Class III | 1 | Terminated |
| 23 May 2014 | RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) Part Number: 10491448 RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests) Part Number: 10491447 RAPIDPoint 500 Measurement… | Device | Class II | 1 | Terminated |
| 22 May 2014 | Siemens RAPIDComm Data Management System. The RAPIDComm Data Management System manages the process of sending and receiving data from Siemens POC devices and hospital systems located in the hospital network, | Device | Class III | 1 | Terminated |
| 20 May 2014 | syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573. | Device | Class II | 1 | Terminated |
| 14 Apr 2014 | Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement part: SMN 10706557 SKIT Air Compressor Assy, used on the Dimension Vista 500 and Dimension Vista 1500 systems. Siemens Healthcare Diagnostics Dimension Vista System is an in vitro diagnostic device intended to duplicate manual… | Device | Class II | 1 | Terminated |
| 10 Apr 2014 | ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491072; Siemens Material Number: 10282378. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers. | Device | Class II | 7 | Terminated |
| 25 Mar 2014 | Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 10310308 (100 tests) Cat No. 00203473 SMN 10331250 (Ref) (500 tests) Cat No. 09132781 SMN 10340209 (Ref) (2500 tests) For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using… | Device | Class II | 1 | Terminated |
| 19 Mar 2014 | Dimension Vista CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients. | Device | Class II | 1 | Terminated |
| 6 Jan 2014 | Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System. | Device | Class II | 1 | Terminated |
| 18 Dec 2013 | ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems | Device | Class II | 2 | Terminated |
| 17 Dec 2013 | Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine. | Device | Class II | 1 | Terminated |
| 5 Dec 2013 | Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements are used as an aid in the management of heart, liver, and kidney transplant patients. | Device | Class II | 1 | Terminated |
| 6 Nov 2013 | Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also known as Clinical Chemistry Systems) are high throughput instruments which perform assays for general and specialty chemistries, methods for specific protein measurement,… | Device | Class II | 1 | Terminated |
| 30 Oct 2013 | Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an… | Device | Class II | 1 | Terminated |
| 7 Oct 2013 | User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as… | Device | Class II | 1 | Terminated |
| 18 Sep 2013 | Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and ETDA plasma on the Dimension Vista System. Measurements of homocysteine aid in the diagnosis and treatment of… | Device | Class II | 1 | Terminated |
| 17 Sep 2013 | Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibration of the cardiac troponin I (TNI) method for the Dimension clinical EXL integrated chemistry system with LOCI module. | Device | Class II | 1 | Terminated |
| 30 Aug 2013 | Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay | Device | Class II | 1 | Terminated |
| 21 Aug 2013 | Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. | Device | Class I | 11 | Terminated |
| 16 Aug 2013 | ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems. | Device | Class III | 1 | Terminated |
| 13 Aug 2013 | Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 A clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, the laboratory information system (LIS) and… | Device | Class II | 1 | Terminated |
| 25 Jul 2013 | ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells. | Device | Class II | 4 | Terminated |
| 1 Jul 2013 | Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage: The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension clinical chemistry system. Measurements of Tacrolimus are used as an aid in the… | Device | Class II | 1 | Terminated |
| 28 Jun 2013 | ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF). For calibrating the following assays using the ADVIA Centaur or ACS:180 systems: FT3, T3, T4, Tup, FT4, THEO2. | Device | Class III | 1 | Terminated |
| 25 Jun 2013 | ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the quantitative determination of total homocysteine… | Device | Class II | 1 | Terminated |
| 19 Jun 2013 | Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. In vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body… | Device | Class II | 1 | Terminated |
| 5 Jun 2013 | Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic product intended to be used to calibrate the Creatine Kinase MB Isozyme method for the Dimension(R) clinical chemistry system with heterogeneous immunoassay module. | Device | Class II | 1 | Terminated |
| 20 May 2013 | Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. Diagnostic device intended to determine a variety of analytes in human body fluids. | Device | Class II | 1 | Terminated |
| 14 May 2013 | ADVIA Centaur iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH). | Device | Class II | 4 | Terminated |
| 10 May 2013 | ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). | Device | Class II | 6 | Terminated |
| 10 May 2013 | syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverification, integrated QC capabilities, browser-based connectivity supporting up to 25 concurrent users, remote services to… | Device | Class II | 1 | Terminated |
| 6 May 2013 | Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module | Device | Class II | 1 | Terminated |
| 2 May 2013 | Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility. | Device | Class II | 1 | Terminated |
| 25 Apr 2013 | Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension(R) clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of Tacrolimus therapy in kidney and liver… | Device | Class II | 1 | Terminated |
| 22 Apr 2013 | HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in… | Device | Class II | 2 | Terminated |
| 13 Mar 2013 | ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit D. | Device | Class II | 4 | Terminated |
| 11 Mar 2013 | Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT). | Device | Class II | 1 | Terminated |
| 6 Mar 2013 | Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp. | Device | Class II | 1 | Terminated |
| 27 Feb 2013 | Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a variety of analytes in human body fluids. | Device | Class III | 3 | Terminated |
| 26 Feb 2013 | CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946. | Device | Class III | 1 | Terminated |
| 22 Feb 2013 | Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus (PHOS) method used on the Dimension(R) clinical chemistry system is an in vitro diagnostic test intended for the quantitative measurement of phosphorus in human serum, plasma, and urine. | Device | Class II | 1 | Terminated |
| 21 Feb 2013 | Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product. | Device | Class II | 1 | Terminated |
| 20 Dec 2012 | Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An in vitro diagnostic test intended to quantitatively measure Total Iron Binding Capacity in human serum. | Device | Class III | 1 | Terminated |
| 20 Dec 2012 | Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the Iron method for the Dimension(R) clinical chemistry system. | Device | Class III | 1 | Terminated |
| 19 Dec 2012 | Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Lot 11349BB The Urinary / Cerebrospinal Fluid Protein method is an in vitro diagnostic test for the quantitive measurement of protein in urine and cerebrospinal fluid on the Dimension Vista System. | Device | Class II | 1 | Terminated |
| 10 Dec 2012 | Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous enzyme immunoassay intended for use in the quantitative analysis of Phenobarbital in human serum or plasma. | Device | Class II | 1 | Terminated |
| 6 Dec 2012 | Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Calibrators are intended for use with the Emit(R) tox(TM) Serum Barbiturate and Benzodiazepine Assays as a reference for the semi-quantitative analis of barbiturates and benzodiazepines in human serum. | Device | Class III | 1 | Terminated |
| 27 Nov 2012 | Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test. | Device | Class II | 1 | Terminated |
| 21 Nov 2012 | Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX positive and negative control strips provide defined results for glucose,… | Device | Class II | 7 | Terminated |
| 14 Nov 2012 | Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 100 Test 02816138 10309045, 10309044 028 Intended Use For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is… | Device | Class II | 7 | Terminated |
| 11 Oct 2012 | Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate sample handling and processing in the clinical laboratory. | Device | Class II | 1 | Terminated |
| 10 Oct 2012 | Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista" System. | Device | Class III | 1 | Terminated |
| 9 Oct 2012 | ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 03439230 (2 pack) | Device | Class II | 3 | Terminated |
| 8 Oct 2012 | Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro diagnostic test for the quantitative determination of iron in human serum and plasma on the Dimension Vista(R) System. Measurements of iron are used in the diagnosis and treatment of diseases such as iron deficiency anemia and… | Device | Class II | 1 | Terminated |
| 17 Sep 2012 | Siemens RAPIDPoint 400 system blood gas analyzer Product Usage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the… | Device | Class II | 7 | Terminated |
| 11 Sep 2012 | Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tests) Not CE Marked; OUS: REF03204829(10310271)(50 Tests); REF 01157807(1 0314722) (250 Tests) CE Marked; REF 09010686 (10340081)(250 Tests). The ADVIA Centaur BR assay is an in vitro diagnostic test… | Device | Class II | 1 | Terminated |
| 9 Aug 2012 | Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO method is an in vitro diagnostic test for the quantitative measurement of Theophylline in human serum and plasma on the Dimension Vista(R) system. | Device | Class II | 1 | Terminated |
| 7 Aug 2012 | ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP Prolactin assay: For in vitro diagnostic use in the quantitative… | Device | Class III | 2 | Terminated |
| 3 Aug 2012 | Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantitative measurement of total homocysteine (HCYS) in human serum, heparinized plasma, and EDTA plasma on the Dimension Vista(R) System. Measurements of homocysteine aid in the diagnosis and treatment of… | Device | Class III | 1 | Terminated |
| 30 Jul 2012 | Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital | Device | Class II | 1 | Terminated |
| 25 Jul 2012 | Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems. Catalog Numbers: 2 Pack REF 07907174 (110312) 6 Pack REF 07293184 (110313). Used for automated dilutions for the ADVIA Centaur BNP and TSH3… | Device | Class II | 1 | Terminated |
| 17 Jul 2012 | Siemens ADVIA Centaur Syphilis (SYPH) Assay, 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA Centaur Syphilis (SYPH) assay is an in vitro diagnostic immunoassay for the qualitative determination of antibodies to Treponema pallidum in human serum or plasma (EDTA, lithium or sodium heparinized,… | Device | Class II | 1 | Terminated |
| 17 Jul 2012 | Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Healthcare Diagnostics Dimension(R) clinical chemistry analyzers are floor model, fully automated, microprocessor-controlled, integrated instrument systems that use prepackaged Flex(R) reagent test cartridges to measure a variety of analytes in… | Device | Class II | 1 | Terminated |
| 17 Jul 2012 | Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista system. | Device | Class III | 1 | Terminated |
| 7 Jun 2012 | Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDMR CalPak), Catalog No. CDDMR-C is an in-vitro diagnostic product intended to be used for the calibration of the Stratus(R) CS Acute Care(TM) D-dimer )DDMR) method | Device | Class III | 1 | Terminated |
| 7 Jun 2012 | EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-Vitro diagnostics devices. | Device | Class II | 1 | Terminated |
| 7 Jun 2012 | Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments | Device | Class II | 1 | Terminated |
| 29 May 2012 | syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments. | Device | Class II | 1 | Terminated |
| 29 May 2012 | EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device intended tot duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body… | Device | Class II | 1 | Terminated |
| 8 May 2012 | Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge used with the Dimension Vista System for the in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma. | Device | Class II | 1 | Terminated |
| 1 Dec 2010 | BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies | Device | Class II | 1 | Terminated |