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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 1
DIASORIN, INC.
  SUBSTANTIALLY EQUIVALENT 2

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

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 88 88
False Negative Result 13 13
Non Reproducible Results 5 5
Output Problem 4 4
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 103 103
Liver Failure 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1

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