Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
Device Code: 6248
Product Code(s):
ODW 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 CYP
Device Classification Information
| Device Type ID | 6248 |
| Device Name | Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System |
| Physical State | Genotyping Test System |
| Technical Method | Uses DNA Genotyping Technology To Determine Patient Genotype At The Cytochrome P450 2C9 (CYP450 2C9) Locus. |
| Target Area | Clinical Samples (blood, Saliva, Buccal Swab Samples) |
| Regulation Description | Drug Metabolizing Enzyme Genotyping System. |
| Regulation Medical Specialty | Toxicology |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 862.3360 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ODW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 6248 |
| Device | Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System |
| Product Code | ODW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Drug Metabolizing Enzyme Genotyping System. |
| CFR Regulation Number | 862.3360 [🔎] |
TPLC Last Update: 2019-04-02 21:19:21