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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections
Definition A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) in clinical specimens collected from patients suspected of sexually transmitted infections. The device is intended to aid in the diagnosis of non-viral sexually transmitted infections in conjunction with other clinical and laboratory data.
Product CodeQEP
Regulation Number 866.3393
Device Class 2


Premarket Reviews
ManufacturerDecision
BINX HEALTH INC
  SUBSTANTIALLY EQUIVALENT 1
BINX HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
CEPHEID
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 3
ROCHE MOLECULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2

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