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Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System

FDA product code ODW · 6 cleared devices

Class 2 Clinical Toxicology
Regulation
21 CFR 862.3360
Review panel
TX
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2007-09-17 – 2019-05-24

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.

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