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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, mass spectrometry, multiplex genotyping, hereditary thrombophilia related mutations
Regulation Description Factor V Leiden DNA mutation detection systems.
Definition A multiplex genotying test system intended for the qualitative detection and identification of specific thrombophilia related gene mutations from genomic DNA by genomic amplification and mass spectrometry. It is intended as an aid in diagnosis of patients with suspected thrombophilia.
Product CodePHJ
Regulation Number 864.7280
Device Class 2