FDA product code NGZ

Susceptibility Test Plate, Antifungal

Microbiology·Class 2·21 CFR 866.1640
US regulatory classifications
US Product Code (FDA)
NGZ
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.1640
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Medical specialty
Microbiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

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.

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About this record

Susceptibility Test Plate, Antifungal is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.