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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cytochrome p450 2c9 (cyp450 2c9) drug metabolizing enzyme genotyping system
Definition An in vitro diagnostic assay for use in genotyping Cytochrome P450 2C9 (CYP450 2C9) alleles. Information about the CYP2C9 genotype may be used as an aid to clinicians in determining therapeutic strategy for medications that are metabolized by the CYP2C9 gene product.
Product CodeODW
Regulation Number 862.3360
Device Class 2


Premarket Reviews
ManufacturerDecision
AKONNI BIOSYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1

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