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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hepatitis a test (antibody and igm antibody)
Regulation Description Hepatitis A virus (HAV) serological assays.
Product CodeLOL
Regulation Number 866.3310
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 2
DIASORIN, INC.
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 12 12
2022 17 17
2023 36 36
2024 21 21
2025 20 20
2026 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 94 94
False Negative Result 16 16
Output Problem 5 5
Non Reproducible Results 5 5
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Incorrect Measurement 2 2
Insufficient Information 1 1
High Test Results 1 1
Optical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 111 111
Liver Failure 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1

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