FDA Product Code NGZ: Susceptibility Test Plate, Antifungal
Fungal infections pose a significant and growing challenge in immunocompromised patients. FDA product code NGZ covers antifungal susceptibility test plates.
These devices contain panels of antifungal agents in microbroth dilution format to determine the minimum inhibitory concentration of antifungals against fungal isolates from clinical specimens. Results guide selection of antifungal therapy in invasive candidiasis, aspergillosis, and other serious fungal infections.
NGZ devices are Class II medical devices, regulated under 21 CFR 866.1640 and reviewed by the FDA Microbiology panel.
Leading manufacturers include Thermo Fisher Scientific and bioMerieux, Inc..
List of Susceptibility Test Plate, Antifungal devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Susceptibility Test Plate, Antifungal devices (product code NGZ). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →