Panels › Microbiology › Product code NGZ · Class 2
Susceptibility Test Plate, Antifungal
Regulation 866.1640
0510(k)s in 12 months (21 all time)
1recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in NGZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Ab Biomerieux | 11 | 3 |
| Thermo Fisher Scientific | 5 | 0 |
| Trek Diagnostic Systems | 4 | 0 |
| Ab Biodisk | 1 | 0 |
| Remel, Inc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2026 | Remel, Inc Yeastone Broth, 11ML, 10/BOX
YY3462 Open, Classified |
NGZ | K090968 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333 Open, Classified |
NGZ | K040560 |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226 Open, Classified |
NGZ | K032399 |
| May 22, 2017 | Biomerieux Inc VITEK 2 Gram Fungal Susceptibility card (AST-YS05), REF 411945, 20 cards per carton. Terminated |
NGZ | None listed |
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