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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device enzyme linked immunosorbent assay, herpes simplex virus, hsv-2
Product CodeMYF
Regulation Number 866.3305
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOKIT, S.A.
  SUBSTANTIALLY EQUIVALENT 1
QUEST INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1 1
2021 2 2
2023 250 250

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 190 190
Incorrect, Inadequate or Imprecise Result or Readings 60 60
Low Test Results 1 1
Device Remains Activated 1 1
False Negative Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 149 149
Insufficient Information 102 102
No Consequences Or Impact To Patient 1 1
Viral Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc II Mar-18-2021
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