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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device test, time, partial thromboplastin
Regulation Description Partial thromboplastin time tests.
Product CodeGGW
Regulation Number 864.7925
Device Class 2

MDR Year MDR Reports MDR Events
2020 4 4
2021 4 4
2022 1 1
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 5 5
Low Test Results 4 4
Use of Device Problem 3 3
Manufacturing, Packaging or Shipping Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
Coagulation Disorder 1 1
No Known Impact Or Consequence To Patient 1 1

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