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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, nucleic acid amplification test, dna, antimicrobial resistance marker, direct specimen
Regulation Description Antimicrobial susceptibility test powder.
Definition To detect the presence of genetic markers of antimicrobial resistance by testing directly from clinical specimens using nucleic acid amplification technology.
Product CodePOC
Regulation Number 866.1640
Device Class 2


Premarket Reviews
ManufacturerDecision
Cepheid
  SUBSTANTIALLY EQUIVALENT 1

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