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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
Regulation Description Herpes simplex virus serological assays.
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


Premarket Reviews
ManufacturerDecision
BD
  SUBSTANTIALLY EQUIVALENT 1
QUIDEL CORP.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate test results 4
False positive result 2
Total Device Problems 6

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