Device type
Susceptibility Test Plate, Antifungal
Product code NGZ · Class II · 21 CFR 866.1640 · Microbiology
The device is an in vitro diagnostic device intended for use in determining quantitative susceptibility of Candida species to various antifungal agents diluted in varying concentration in a microtiter plate format.
Recent 510(k)s
No 510(k) clearances in the archive for NGZ.
Recent recalls
Nov 3, 2026
Z-0355-2027
Yeastone Broth, 11ML, 10/BOX, used in antibiotic susceptibility testing of mycological clinical specimens
Remel, Inc
- NGZ
- Class II
- Open, Classified