NHS — Assay, Genotype, Hiv Drug Resistance, In Vitro Class II

FDA Device Classification

FDA product code NHS covers "Assay, Genotype, Hiv Drug Resistance, In Vitro", a Class II medical device regulated under 21 CFR 866.3950. Submissions are reviewed by the Immunology panel.

Classification Details

Product Code
NHS
Device Class
Class II
Regulation Number
866.3950
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Definition

Hiv-1 drug resistance genotyping