Home › Device types › NGZ
Susceptibility Test Plate, Antifungal
FDA product code NGZ · Class 2 · Microbiology
18
Registered devices
53
Adverse events
4
Recalls
21
510(k) clearances
Devices with this code
ETEST® Fluconazole (FL) — BIOMERIEUX SAETEST® Flucytosine (FC) — BIOMERIEUX SASensititre — TREK DIAGNOSTIC SYSTEMS LIMITEDNA — REMEL, INC.VITEK® 2 AST-YS09 — BIOMERIEUX , INC.ETEST® Voriconazole (VO) — BIOMERIEUX SASensititre — TREK DIAGNOSTIC SYSTEMS LIMITEDETEST® Flucytosine (FC) — BIOMERIEUX SAEtest® FLUCONAZOLE — BIOMERIEUX SAVITEK® 2 AST-YS05 — BIOMERIEUX , INC.Sensititre — TREK DIAGNOSTIC SYSTEMS LIMITEDSensititre — TREK DIAGNOSTIC SYSTEMS LIMITEDETEST® Itraconazole (IT) — BIOMERIEUX SASensititre — TREK DIAGNOSTIC SYSTEMS LIMITEDSENSITITRE YEASTONE SUSCEPTIBILITY PLATES — REMEL, INC.ETEST® Fluconazole (FL) — BIOMERIEUX SASensititre — TREK DIAGNOSTIC SYSTEMS LIMITEDEtest® ITRACONAZOLE — BIOMERIEUX SA
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-24 | Remel, Inc | Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal a |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2017-04-20 | Biomerieux Inc | The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.