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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device herpes simplex virus nucleic acid amplification assay
Definition A polymerase chain reaction (pcr)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (hsv) dna using vaginal swab specimens.
Product CodeOQO
Regulation Number 866.3305
Device Class 2

MDR Year MDR Reports MDR Events
2024 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Sleep Dysfunction 1 1
Weight Changes 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Depression 1 1
Suicidal Ideation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DiaSorin Molecular LLC II Jul-10-2020
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