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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device assay, heparin
Regulation Description Heparin assay.
Product CodeKFF
Regulation Number 864.7525
Device Class 2


Premarket Reviews
ManufacturerDecision
INSTRUMENTATION LABORATORY CO
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 4 4
2022 1 1
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 10 10
False Negative Result 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12

Recalls
Manufacturer Recall Class Date Posted
1 Diagnostica Stago, Inc. II Aug-28-2025
2 Instrumentation Laboratory II Aug-13-2025
3 Instrumentation Laboratory II Jan-24-2025
4 Instrumentation Laboratory II Sep-30-2024
5 Instrumentation Laboratory II Oct-19-2021
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