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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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.
Product CodeNGZ
Regulation Number 866.1640
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 7
Trek Diagnostic Systems
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Incorrect or inadequate result 6
Total Device Problems 6

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