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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
ABBOTT MOLECULAR INC.
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT MOLECULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
BECTON DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BINX HEALTH INC
  SUBSTANTIALLY EQUIVALENT 1
BINX HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
CEPHEID
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 4
NEUMODX MOLECULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
RHEONIX, INC
  SUBSTANTIALLY EQUIVALENT 1
ROCHE MOLECULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
VISBY MEDICAL
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 1 1
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 2 2
False Positive Result 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
Insufficient Information 1 1
Sexually Transmitted Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Binx Health, Inc. II May-23-2023
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