| 4 Jun 2026 | VITEK 2 AST-N447 TEST KIT Product reference 424620 | Device | Class II | 1 | Ongoing |
| 5 Jan 2026 | VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARD NAME/ PRODUCT REFERENCE: AST-N399 423701 AST-N402 423644 AST-N403 423645 AST-N404 423664 AST-N405 423864 AST-N406… | Device | Class II | 1 | Ongoing |
| 26 Jun 2025 | VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export only | Device | Class II | 1 | Ongoing |
| 14 Mar 2024 | VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340; e) AST-N391, REF 423341; f) AST-N392, REF 423342; g) AST-N395, REF 423491; h) AST-N401, REF 423643; i) AST-N402, REF 423644; j)… | Device | Class I | 1 | Ongoing |
| 6 Feb 2023 | MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (LIS). | Device | Class II | 1 | Ongoing |
| 9 Nov 2022 | API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300 | Device | Class II | 94 | Ongoing |
| 20 Jul 2022 | NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit. | Device | Class II | 1 | Ongoing |
| 13 Jul 2022 | VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9 | Device | Class II | 1 | Ongoing |
| 29 Mar 2022 | VITEK 2 Systems and VITEK 2 with MYLA. | Device | Class II | 1 | Ongoing |
| 9 Feb 2022 | VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx. | Device | Class II | 1 | Terminated |
| 20 Dec 2021 | API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses miniaturized tests as well as a specially adapted database. After manual inoculation of the strip, reading can be performed either automatically or manually and the… | Device | Class II | 1 | Terminated |
| 9 Nov 2021 | RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD. | Device | Class II | 1 | Terminated |
| 30 Sep 2021 | API 50 CH, Model 50300 | Device | Class II | 1 | Terminated |
| 22 Sep 2021 | VIDAS PRG Progesterone, REF 30409-01 | Device | Class II | 16 | Ongoing |
| 24 Jun 2021 | ETEST IMIPENEM RELEBACTAM. in vitro diagnostic | Device | Class II | 1 | Terminated |
| 16 Mar 2021 | VIDAS¿ CMV IgM 30 Tests | Device | Class II | 1 | Terminated |
| 28 Jan 2021 | VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and… | Device | Class II | 2 | Terminated |
| 11 Mar 2020 | The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed. | Device | Class II | 1 | Ongoing |
| 5 Feb 2020 | VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK… | Device | Class II | 1 | Terminated |
| 24 Jan 2020 | PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units), P1028888-001 PSU (used in Zebra LP2824 Plus printers) PSUs with the following date code; 0639XX through 1253XX (YYWWXX, where YY=Year, and WW=week). | Device | Class II | 1 | Terminated |
| 10 Dec 2019 | VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit | Device | Class II | 1 | Terminated |
| 22 Oct 2019 | BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation | Device | Class II | 1 | Terminated |
| 15 Mar 2019 | Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. | Device | Class II | 1 | Terminated |
| 13 Dec 2018 | VITEK 2 AST-N351 Test Kit | Device | Class II | 1 | Terminated |
| 13 Nov 2018 | VITEK¿ 2 Systems Software Version 9.01 Update Kit. | Device | Class II | 1 | Terminated |
| 22 Oct 2018 | VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST01 Catalog # 420915, VITEK 2 AST-ST02 Catalog # 421040, VITEK 2 AST-ST03 The VITEK 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 Systems in clinical… | Device | Class II | 1 | Terminated |
| 8 Oct 2018 | bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134 | Device | Class II | 1 | Terminated |
| 13 Aug 2018 | VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 418579 Product Usage: VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility… | Device | Class II | 2 | Terminated |
| 27 Jun 2018 | BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and… | Device | Class II | 3 | Terminated |
| 1 Mar 2018 | VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for use on the VIDAS family instruments for the determination of human luteinizing hormone in human serum or plasma (lithium heparin), using the ELFA technique (Enzyme Linked Fluorescent Assay) | Device | Class II | 1 | Terminated |
| 26 Jan 2018 | bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card Cefotoxin and AST for Oxacillin bioMerieux VITEK 2 AST-P631 bioMerieux VITEK 2 AST-GP67 Test Kit bioMerieux VITEK 2 AST-GP71 Test Kit bioMerieux VITEK 2 AST-GP75 Test Kit bioMerieux… | Device | Class I | 1 | Terminated |
| 23 Jan 2018 | bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast. | Device | Class II | 1 | Terminated |
| 4 Jan 2018 | BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS¿ system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical systems. Specifically the mini VIDAS system… | Device | Class II | 2 | Terminated |
| 11 Oct 2017 | VITEK2 GP-ID, REF 21342 IVD | Device | Class II | 1 | Terminated |
| 25 Aug 2017 | VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growth based biochemical patterns to… | Device | Class II | 1 | Terminated |
| 12 Jul 2017 | VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast. | Device | Class II | 2 | Terminated |
| 16 May 2017 | VITEK 2 Gram Negative test kits containing colistin (cs01n) | Device | Class II | 1 | Terminated |
| 15 May 2017 | VIDAS Testosterone, Ref 30418 | Device | Class II | 1 | Terminated |
| 20 Apr 2017 | VITEK¿ 2 Gram-Negative identification card (GN), IVD, REF 21341, 20 cards per carton. | Device | Class II | 187 | Terminated |
| 10 Apr 2017 | eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens, with liquid and homogeneous properties (as part of their natural characteristics or after pre-treatment). | Device | Class II | 1 | Terminated |
| 24 Feb 2016 | Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S.… | Device | Class I | 9 | Terminated |
| 24 Feb 2016 | VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The… | Device | Class II | 1 | Terminated |
| 24 Dec 2015 | BacT/ALERT¿ SN, bioM¿rieux, Inc. Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast). | Device | Class II | 2 | Terminated |
| 23 Nov 2015 | Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens. | Device | Class II | 1 | Terminated |
| 3 Nov 2015 | MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application ( Middleware ) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)). | Device | Class II | 7 | Terminated |
| 14 Apr 2015 | MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer application software. MYLA V3 is a computer application ("Middleware") based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s). | Device | Class II | 1 | Terminated |
| 27 Mar 2015 | Vitek 2 AST-YS06 REF 412 610, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed. | Device | Class II | 3 | Terminated |
| 25 Feb 2015 | Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae. | Device | Class III | 3 | Terminated |
| 10 Feb 2014 | bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO. | Device | Class II | 1 | Terminated |
| 6 Sep 2013 | chromID Salmonella Agar, Reference No. 43621. A selective isolation and differentiation medium for the detection of Salmonella in human specimens. | Device | Class II | 1 | Terminated |
| 14 Jun 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, V2S 6.01 RP5800-WES7 Media. Part number: 413861. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial… | Device | Class II | 15 | Terminated |
| 18 Feb 2013 | VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7, Cat. #413862; (5) dc7100 8-port, Cat. #W0441; (6) dc7100 8-port (refurbished), Cat. #W0441R; (7) dc7700 8-port, Cat.… | Device | Class II | 3 | Terminated |
| 6 Feb 2013 | bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents. | Device | Class II | 1 | Terminated |
| 25 Dec 2012 | BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids. | Device | Class II | 1 | Terminated |
| 17 Oct 2012 | 0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: The concentrated sodium chloride is used to prepare inoculum that is analyzed by the VITEK 2 instrument. The VITEK 2 user manual instructs all users to prepare inoculum with 0.45%-0.50% sodium chloride injections, and the system is designed to… | Device | Class II | 1 | Terminated |
| 16 Oct 2012 | bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources… | Device | Class II | 31 | Terminated |
| 28 Aug 2012 | PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples. | Device | Class II | 1 | Terminated |