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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device trichomonas vaginalis nucleic acid amplification test system
Regulation Description Trichomonas vaginalis nucleic acid assay.
Definition In vitro nucleic acid amplification test for the qualitative detection of ribosomal rna from trichomonas vaginalis as an aid in the diagnosis of trichomoniasis from vaginal, cervical, urogenital and gynecological specimens from symptomatic patients
Product CodeOUY
Regulation Number 866.3860
Device Class 2


Premarket Reviews
ManufacturerDecision
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON, AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
CEPHEID
  SUBSTANTIALLY EQUIVALENT 1
QUIDEL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
False Positive Result 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Aug-22-2019
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