Assay, Genotyping, Hepatitis C Virus
Device Code: 3614
Product Code(s):
OBF Definition: In Vitro Diagnostic Device For Qualitative Detection And Classification Of 8 Clinically Relevant Hepatitis C Virus RNA Genotypes
Device Classification Information
| Device Type ID | 3614 |
| Device Name | Assay, Genotyping, Hepatitis C Virus |
| Physical State | RT-PCR Amplification |
| Technical Method | In Vitro Diagnostic Device For Qualitative Detection And Classification Of 8 Clinically Relevant Hepatitis C Virus RNA Genotypes |
| Target Area | Human Specimens |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OBF |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3614 |
| Device | Assay, Genotyping, Hepatitis C Virus |
| Product Code | OBF |
| FDA Device Classification | Class 3 Medical Device |
TPLC Last Update: 2019-04-02 20:33:13