Panels › Microbiology › Product code LQL · Class 1
Gram Positive Identification Panel
Regulation 866.2660
0510(k)s in 12 months (11 all time)
1recalls in 12 months (7 all time)
2recalls that name a 510(k)
Top companies in LQL
| Company | 510(k)s | Recalls |
|---|---|---|
| BioMerieux SA | 0 | 6 |
| Biomerieux Vitek, Inc. | 2 | 0 |
| Accumed Intl., Inc. | 1 | 0 |
| American Micro Scan | 1 | 0 |
| Analytical Products, Inc. | 1 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| Becton Dickinson Microbiology Systems | 1 | 0 |
| Dms Products, Inc. | 1 | 0 |
| Kev Connecticut Diagnostics, Inc. | 1 | 0 |
| Mct Medical, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2026 | Oxoid Australia Pty Limited OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem Open, Classified |
LQL | None listed |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345 Open, Classified |
LQL | None listed |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342 Open, Classified |
LQL | None listed |
| Mar 23, 2018 | BioMerieux SA The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated identification of most significant Gram-positive organisms. The VITEK 2 GP identificat Terminated |
LQL | None listed |
| Oct 11, 2017 | Biomerieux Inc VITEK2 GP-ID, REF 21342 IVD Terminated |
LQL | K952095 |
| Aug 25, 2017 | Biomerieux Inc 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 antimic Terminated |
LQL | K952095 |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram-Positive identification card (GP), IVD, REF 21342, 20 cards per carton. Terminated |
LQL | None listed |
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