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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, carbapenem non-susceptible gram negative organism, colony
Regulation Description Antimicrobial susceptibility test powder.
Definition To detect the presence of genetic markers of antimicrobial resistance by testing isolated bacterial colonies using nucleic acid amplification technology.
Product CodePMY
Regulation Number 866.1640
Device Class 2


Premarket Reviews
ManufacturerDecision
GENEPOC, INC.
  SUBSTANTIALLY EQUIVALENT 1
OPGEN, INC.
  SUBSTANTIALLY EQUIVALENT 1

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