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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device test 5, 10-methylenetetrahydrofolate reductase mutations, genomic dna pcr
Regulation Description Factor V Leiden DNA mutation detection systems.
Definition In vitro diagnostic for the detection and genotyping of a single point mutation of the human 5, 10-methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia.
Product CodeOMM
Regulation Number 864.7280
Device Class 2


Premarket Reviews
ManufacturerDecision
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
High test results 1
Total Device Problems 1

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