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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device positive blood culture processor for inoculum preparation used for antimicrobial susceptibility testing
Definition Processing device that includes associated reagents, when applicable, that is intended to recover microbes from positive blood cultures for inoculum preparation. The prepared inoculum is intended for subsequent use in antimicrobial susceptibility testing.
Product CodeQZX
Regulation Number 866.1650
Device Class 2


Premarket Reviews
ManufacturerDecision
AVAILS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SELUX DIAGNOSTICS, INC
  SUBSTANTIALLY EQUIVALENT 1

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