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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
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 7 7
2022 16 16
2023 3 3
2024 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GET TESTED INTERNATIONAL AB II Dec-01-2025
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