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U.S. Department of Health and Human Services

Product Classification

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Device susceptibility test plate, antifungal
Regulation Description Antimicrobial susceptibility test powder.
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.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeNGZ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.1640
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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