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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-1
Product CodeMXJ
Regulation Number 866.3305
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-RAD LABORATORIES
  SUBSTANTIALLY EQUIVALENT 2
BIOKIT, S.A.
  SUBSTANTIALLY EQUIVALENT 2
GOLD STANDARD DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
QUEST INTERNATIONAL, INC
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2
THERANOS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZEUS SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2016 2 2
2017 1 1
2018 1 1
2019 1 1
2021 2 2
2023 140 140
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 114 114
Incorrect, Inadequate or Imprecise Result or Readings 28 28
Low Test Results 4 4
False Negative Result 1 1
Incorrect Or Inadequate Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 93 93
Insufficient Information 48 48
No Consequences Or Impact To Patient 4 4
No Known Impact Or Consequence To Patient 2 2
Anxiety 1 1
Viral Infection 1 1
No Information 1 1

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