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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device antithrombin iii quantitation
Product CodeJBQ
Regulation Number 864.7060
Device Class 2


Premarket Reviews
ManufacturerDecision
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 1 1
Low Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2

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