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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 252 254
2024 13 13
2025 49 49
2026 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 260 260
Incorrect, Inadequate or Imprecise Result or Readings 62 62
False Negative Result 3 5
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 223 223
Insufficient Information 104 104
Anxiety 6 6
Depression 4 4
Viral Infection 2 4
Sleep Dysfunction 1 1
Rash 1 1
Burning Sensation 1 1
Needle Stick/Puncture 1 1
Distress 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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