QST

Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test

Product code: QST
Device name: Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test
Device class: Class 2
21 CFR: 21 CFR 866.3957
Medical specialty: Microbiology
Marketing pathway: 510(K)

FDA classification definition

Human immunodeficiency virus (HIV) lab-based nucleic acid diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV nucleic acid in human body fluids or tissues.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QST

Classification and pathway per current FDA publications. Data from openFDA (CC0).