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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
Regulation Description Herpes simplex virus serological assays.
Product CodeMYF
Regulation Number 866.3305
Device Class 2


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

MDR Year MDR Reports MDR Events
2021 2 2
2023 252 252
2024 13 13
2025 1 1

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 158 158
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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