Assay, Genotype, Hiv Drug Resistance, In Vitro
Device Code: 3060
Product Code(s):
NHS Definition: Hiv-1 Drug Resistance Genotyping
Device Classification Information
| Device Type ID | 3060 |
| Device Name | Assay, Genotype, Hiv Drug Resistance, In Vitro |
| Regulation Description | In Vitro Human Immunodeficiency Virus (HIV) Drug Resistance Genotype Assay. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3950 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NHS |
| 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 | 3060 |
| Device | Assay, Genotype, Hiv Drug Resistance, In Vitro |
| Product Code | NHS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | In Vitro Human Immunodeficiency Virus (HIV) Drug Resistance Genotype Assay. |
| CFR Regulation Number | 866.3950 [🔎] |
| Device Problems |
|---|
False Positive Result | 2 |
| Total Device Problems | 2 |
TPLC Last Update: 2019-04-02 20:23:14