Gram Negative Identification Panel
FDA product code LQM · Class I (low risk) · 21 CFR 866.2660 · Microbiology
7510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K923313 | Roche Oxi/Ferm IILQM · Traditional | Roche Diagnostic Systems, Inc. | 04/05/1993SE |
| K925915 | Vitek Rapid Call-Gram Negativ Ident CardLQM · Traditional | Biomerieux Vitek, Inc. | 03/23/1993SE |
| K912897 | Sceptor Identification SystemLQM · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/28/1991SE |
| K911429 | Vitek Gram Negative Identification Card, ModifiedLQM · Traditional | Vitek Systems, Inc. | 06/24/1991SE |
| K890057 | Sensititre Auto Id Plate AP80LQM · Traditional | Radiometer America, Inc. | 06/09/1989SE |
| K862642 | Gram Negative Fluorescent Identification PanelLQM · Traditional | American Micro Scan | 09/11/1986SE |
| K851528 | Pasco Gram Negative Identification SystemLQM · Traditional | Pasco Laboratories, Inc. | 07/15/1985SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0787-2023 Class II | VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Biomerieux Inc | 11/09/2022Open, Classified |
| Z-2341-2017 Class II | VITEK 2 Gram-Negative identification card (GN), IVD, REF 21341, 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 |