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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device test, factor v leiden mutations, genomic dna pcr
Definition In vitro diagnostic test to detect the Factor V Leiden mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
Product CodeNPQ
Regulation Number 864.7280
Device Class 2

MDR Year MDR Reports MDR Events
2017 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Improper or Incorrect Procedure or Method 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1 1
No Code Available 1 1

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