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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
Regulation Description Factor V Leiden DNA mutation detection systems.
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

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