Data / Medical devices / Susceptibility Test Plate, Antifungal
Susceptibility Test Plate, Antifungal (NGZ): 6 FDA-registered makers in 3 countries
6 establishments in 3 countries are registered with the FDA to make Susceptibility Test Plate, Antifungal (product code NGZ, Class 2, 21 CFR 866.1640). 5 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 21 510(k) clearances under this code, the latest on February 27, 2025, and lists 3 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- NGZ
- Device class
- 2
- Regulation
- 866.1640
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| United Kingdom | 2 |
| France | 1 |
Makers of Susceptibility Test Plate, Antifungal
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Biomerieux, Inc. | Hazelwood, MO, United States | Manufacturer, Manufacturer for export | 9 | June 12, 2024 | 0 | 2 | 0 | api.fda.gov |
| Trek Diagnostic Systems, Ltd. | East Grinstead West Sussex, United Kingdom | Exporter to the US, Manufacturer | 5 | August 31, 2023 | 0 | 0 | 0 | api.fda.gov |
| Biomerieux SA | LA BALME LES GROTTES Isere, France | Manufacturer | 2 | November 2, 2009 | 0 | 0 | 0 | api.fda.gov |
| Remel, Inc. | Lenexa, KS, United States | Manufacturer, Specification developer | 2 | January 31, 2014 | 0 | 1 | 0 | api.fda.gov |
| Remel Cleveland, A Division of Remel Inc. | Oakwood Village, OH, United States | Specification developer | 1 | January 31, 2014 | 0 | 0 | 0 | api.fda.gov |
| Remel Europe Ltd | Dartford, Kent, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 27, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.