QICClass II

Hiv-1 Genotyping Assay Using Ngs Technology

21 CFR 866.3955 / Medical Genetics

QIC is the FDA product code for Hiv-1 Genotyping Assay Using Ngs Technology, a class II device type, regulated under 21 CFR 866.3955. FDA's definition for this code reads: "The human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing (NGS) technology is a prescription in vitro diagnostic device intended for use in detecting HIV genomic mutations that confer resistance to specific anti-retroviral drugs. The device is intended to be used as an...". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: QIC
Device name: Hiv-1 Genotyping Assay Using Ngs Technology
FDA definition: The human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing (NGS) technology is a prescription in vitro diagnostic device intended for use in detecting HIV genomic mutations that confer resistance to specific anti-retroviral drugs. The device is intended to be used as an aid in monitoring and treating HIV infection.
Regulation: 21 CFR 866.3955
Device class: Class II
Review panel: Medical Genetics
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code QIC

FDA records hold no clearances under product code QIC.

Recent recalls

Product code QIC

FDA records show no recalls under product code QIC.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)