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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, genotypic detection, resistant markers, enterococcus species
Regulation Description Antimicrobial susceptibility test powder.
Definition The in vitro device is intended to detect the presence of the vanA and vanB genes in isolated colonies of Enterococcus spp. as a marker for vancomycin resistance using DNA probe technology
Product CodeNIJ
Regulation Number 866.1640
Device Class 2


Premarket Reviews
ManufacturerDecision
CEPHEID®
  SUBSTANTIALLY EQUIVALENT 1

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