Gram Positive Identification Panel
FDA product code LQL · Class I (low risk) · 21 CFR 866.2660 · Microbiology
11510(k) clearances
0PMA approvals
7recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972576 | Gram Positive Autoidentification Plates, Sensititre AP90LQL · Traditional | Accumed Intl., Inc. | 01/22/1998SE |
| K961968 | Bblcrystal Gram-Positive Id SystemLQL · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 02/04/1997SE |
| K961730 | Rapid Gram-Positive Id SystemLQL · Traditional | Becton Dickinson Microbiology Systems | 02/04/1997SE |
| K952095 | Vitek Gram Positive Identification Card (Gpi)LQL · Traditional | Biomerieux Vitek, Inc. | 03/12/1996SE |
| K925916 | Vitek Rapid Call-Gram Positive Identification CardLQL · Traditional | Biomerieux Vitek, Inc. | 03/23/1993SE |
| K910304 | Rapid Coryne Syst/Identif of Coryneform BacteriaLQL · Traditional | Vitek Systems, Inc. | 07/26/1991SE |
| K910537 | Visi-StrepLQL · Traditional | Kev Connecticut Diagnostics, Inc. | 04/12/1991SE |
| K901559 | Modification to Api Uniscept 20GPLQL · Traditional | Analytical Products, Inc. | 09/10/1990SE |
| K891004 | Rapidec StaphLQL · Traditional | Dms Products, Inc. | 11/09/1989SE |
| K874606 | Cathra Gram Positive ScreenLQL · Traditional | Mct Medical, Inc. | 05/06/1988SE |
| K863038 | Gram Positive Fluorescent Identification PanelLQL · Traditional | American Micro Scan | 09/30/1986SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1766-2026 Class II | OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification…Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873… | Oxoid Australia Pty Limited | 03/03/2026Open, Classified |
| Z-0790-2023 Class II | VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Biomerieux Inc | 11/09/2022Open, Classified |
| Z-0788-2023 Class II | VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Biomerieux Inc | 11/09/2022Open, Classified |
| Z-2164-2018 Class II | The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2…A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits.… | BioMerieux SA | 03/23/2018Terminated |
| Z-0074-2018 Class II | VITEK2 GP-ID, REF 21342 IVDCustomers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R… | Biomerieux Inc | 10/11/2017Terminated |
| Z-3134-2017 Class II | VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an…Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus… | Biomerieux Inc | 08/25/2017Terminated |
| Z-2342-2017 Class II | VITEK 2 Gram-Positive identification card (GP), IVD, REF 21342, 20 cards per carton.The integrity of the product container may be compromised thereby exposing product to moisture which could… | Biomerieux Inc | 04/20/2017Terminated |