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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


Premarket Reviews
ManufacturerDecision
BECTON DICKINSON & CO.
  SUBSTANTIALLY EQUIVALENT 1
BIOHELIX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ERAGEN BIOSCIENCES
  SUBSTANTIALLY EQUIVALENT 1
ERAGEN BIOSCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
FOCUS DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTELLIGENT MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
QIAGEN
  SUBSTANTIALLY EQUIVALENT 1
QUIDEL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ROCHE MOLECULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SEEGENE
  SUBSTANTIALLY EQUIVALENT 1
VELA DIAGNOSTICS USA INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 6 6
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Or Inadequate Test Results 4 4
False Positive Result 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 6 6
No Clinical Signs, Symptoms or Conditions 1 1

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