Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
- US Product Code (FDA)
- ODWView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 862.3360View CFR Regulation →
- Medical specialty
- Clinical Toxicology
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Eligible
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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Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System is a medical device type in the Clinical Toxicology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
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