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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, factor ii g20210a mutations, genomic dna pcr
Regulation Description Factor V Leiden DNA mutation detection systems.
Definition In vitro diagnostic test to detect the Factor II G20210A mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
Product CodeNPR
Regulation Number 864.7280
Device Class 2


Premarket Reviews
ManufacturerDecision
CEPHEID
  SUBSTANTIALLY EQUIVALENT 1
CEPHEID®
  SUBSTANTIALLY EQUIVALENT 1

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