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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
Product CodeMYF
Regulation Number 866.3305
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOKIT, S.A.
  SUBSTANTIALLY EQUIVALENT 1
QUEST INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
ZEUS SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1 1
2021 2 2
2023 252 252
2024 11 11

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
Low Test Results 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 155 155
Insufficient Information 104 104
Anxiety 4 4
Depression 3 3
Viral Infection 2 2
Sleep Dysfunction 1 1
Needle Stick/Puncture 1 1
No Consequences Or Impact To Patient 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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