21 CFR 866.3950 — Assay, Genotype, Hiv Drug Resistance, In Vitro
Immunology (IM) · Part 866 Subpart D—Serological Reagents · § 866.3950
Identification
The in vitro HIV drug resistance genotype assay is a device that consists of nucleic acid reagent primers and probes together with software for predicting drug resistance/susceptibility based on results obtained with these primers and probes. It is intended for use in detecting HIV genomic mutations that confer resistance to specific antiretroviral drugs, as an aid in monitoring and treating HIV infection.
Classification Rationale
Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay.” See § 866.1(e) for the availability of this guidance document.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| NHS | Assay, Genotype, Hiv Drug Resistance, In Vitro | 2 | 0 |
Special Controls
NHS — Assay, Genotype, Hiv Drug Resistance, In Vitro
*Classification.* Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay.” See § 866.1(e) for the availability of this guidance document.
eCFR
NHS — Assay, Genotype, Hiv Drug Resistance, In Vitro
The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay.” See § 866.1(e) for the availability of this guidance document.
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