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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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
QUEST INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 2 2
2023 252 252
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 192 192
Incorrect, Inadequate or Imprecise Result or Readings 60 60
False Negative Result 3 3
Device Remains Activated 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 157 157
Insufficient Information 104 104
Anxiety 4 4
Depression 3 3
Viral Infection 2 2
Sleep Dysfunction 1 1
Needle Stick/Puncture 1 1
Decreased Appetite 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Diasorin Inc. II Jan-25-2024
2 Siemens Healthcare Diagnostics, Inc II Mar-18-2021
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