| 3 Jun 2026 | GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460 | Device | Class II | 1 | Ongoing |
| 24 Mar 2026 | Yeastone Broth, 11ML, 10/BOX YY3462 | Device | Class II | 1 | Ongoing |
| 5 Feb 2026 | Campy CVA Medium 100/PK, R01272 | Device | Class II | 1 | Ongoing |
| 12 Nov 2025 | 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450 | Device | Class II | 1 | Ongoing |
| 11 Jul 2025 | Blood Agar,5% Sheep Blood 100/PK, Product Number R01202 | Device | Class II | 4 | Ongoing |
| 1 May 2025 | Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device | Device | Class II | 1 | Ongoing |
| 13 Feb 2025 | remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use | Device | Class II | 2 | Ongoing |
| 12 Feb 2025 | Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ | Device | Class II | 1 | Ongoing |
| 20 Sep 2024 | remel BactiDrop Acridine Orange, REF 21502, 50 per package. | Device | Class II | 1 | Ongoing |
| 14 Aug 2023 | remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora | Device | Class II | 1 | Ongoing |
| 31 May 2023 | Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use. | Device | Class II | 1 | Ongoing |
| 20 Oct 2022 | Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST | Device | Class I | 9 | Terminated |
| 10 Jan 2022 | Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format | Device | Class II | 1 | Terminated |
| 18 Jun 2021 | ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom | Device | Class II | 1 | Terminated |
| 22 Apr 2021 | Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screening method for primary isolation and presumptive identification of vancomycin-resistance enterococci (VRE) from surveillance cultures. | Device | Class II | 1 | Terminated |
| 10 Mar 2021 | Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species. | Device | Class II | 2 | Ongoing |
| 10 Dec 2020 | Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049 | Device | Class II | 1 | Terminated |
| 17 Apr 2019 | Thio Med w/Dex, Hem, Vit K (5ml) 100/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes | Device | Class II | 4 | Terminated |
| 17 Apr 2019 | Thio Med w/o Ind, w/Dex (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes | Device | Class II | 10 | Terminated |
| 4 Jan 2019 | SWIN 2017 database, Model YSW4000 | Device | Class II | 1 | Terminated |
| 13 Aug 2018 | remel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K (a) 10ML, REF 07182 (b) 10ML, REF 07180 (c) 5ML, REF 064732 (d) 5ML, REF 064730 (e) 9ML, REF 064720 | Device | Class II | 3 | Terminated |
| 8 Dec 2017 | Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. Product Usage: Suitable for the use in slide agglutination tests to identify Shigella cultures presumptively for epidemiological and diagnostic purposes. | Device | Class II | 1 | Terminated |
| 2 Nov 2017 | CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres. | Device | Class II | 1 | Terminated |
| 24 Mar 2017 | Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215 Product Usage: Blood Agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of hemolytic reactions. | Device | Class II | 1 | Terminated |
| 9 Feb 2017 | Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033, | Device | Class II | 1 | Terminated |
| 24 Mar 2016 | Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection of beta-lactamase activity in bacterial cells. in vitro diagnostic | Device | Class II | 1 | Terminated |
| 6 Nov 2015 | Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes. | Device | Class II | 1 | Terminated |
| 30 Jun 2015 | PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification of beta-hemolytic streptococci of Lancefield Groups A, B, C, F or G from primary culture plates. | Device | Class II | 2 | Terminated |
| 19 May 2015 | VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids. | Device | Class II | 2 | Terminated |
| 4 May 2015 | Remel Blood Agar (TSA w/sheep blood) plate REF R01202 packaged 10 plates per pack, 10/10-packs per case (100 plates). Blood agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of hemolytic reactions. | Device | Class II | 1 | Terminated |
| 5 Feb 2015 | Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England and Oxoid Ltd., Basingstoke, Hants, England. | Device | Class II | 1 | Terminated |
| 13 Nov 2014 | Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplement for the isolation of Legionella. | Device | Class II | 1 | Terminated |
| 29 Oct 2014 | Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain for use in qualitative procedures as a counterstain in the fluorescent microscopic detection of mycobacteria. | Device | Class II | 1 | Terminated |
| 23 Oct 2014 | Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, Lot 1301912. The product is a latex agglutination test for the identification of predominant Legionella species grown on plate… | Device | Class II | 2 | Terminated |
| 17 Oct 2014 | Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growth supplement for the isolation of Legionella. | Device | Class II | 1 | Terminated |
| 11 Jun 2014 | Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS. | Device | Class II | 1 | Terminated |
| 17 Mar 2014 | Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England. | Device | Class II | 2 | Terminated |
| 18 Feb 2014 | Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing. | Device | Class II | 1 | Terminated |
| 24 Jan 2014 | Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm name on the label is Oxoid Ltd., Basingstoke, Hants, England. The product is used for the isolation of Legionella species from clinical and environmental samples. When the product is added to CYE Agar… | Device | Class II | 1 | Terminated |
| 21 Nov 2013 | Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 50 discs per cartridge. Firm name on the label is Oxoid, Ltd., Basingstoke, United Kingdom. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility… | Device | Class II | 1 | Terminated |
| 2 May 2013 | Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label is Remel Europe Ltd., Dartford, England. Streptex is a rapid latex test system for use in the qualitative detection and… | Device | Class II | 2 | Terminated |
| 9 Apr 2013 | Oxoid Antimicrobial Susceptibility Test Discs, Cefpodoxime 10 mcg., CT1612B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing to assist in the… | Device | Class II | 4 | Terminated |
| 4 Apr 2013 | remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of RapID Yeast Plus Reagent A and a 10-ml bottle of RapID Yeast Plus Reagent B. Product Usage: For the biochemical identification of medically important yeast and yeast-like organisms. | Device | Class II | 1 | Terminated |
| 25 Mar 2013 | Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England Product is used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing. | Device | Class III | 1 | Terminated |
| 19 Feb 2013 | Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains 20 Flu A Control Swabs and 20 Flu B Control Swabs, each swab is individually packaged in a foil pouch. The firm name on the label is Remel Europe, Ltd., Dartford, Kent, United Kingdom. Product is a test kit containing… | Device | Class III | 1 | Terminated |
| 21 Nov 2012 | Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box. The firm name on the box label is Oxoid Ltd., Basingstoke, UK. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a… | Device | Class III | 1 | Terminated |
| 10 Oct 2012 | The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionellae from clinical and environmental samples. | Device | Class II | 1 | Terminated |
| 21 Aug 2012 | Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, oxoid@thrmofisher.com (Both Remel & Oxoid, Ltd are a part of Thermo Fisher Scientific) An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used… | Device | Class II | 1 | Terminated |
| 21 Aug 2012 | Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges per box. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hants, UK. | Device | Class II | 1 | Terminated |
| 20 Aug 2012 | Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests, REF 24650. Product Usage: Usage: The test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal specimens. The test is intended for… | Device | Class II | 2 | Terminated |