QSU

Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test

Product code: QSU
Device name: Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test
Device class: Class 2
21 CFR: 21 CFR 866.3956
Medical specialty: Microbiology
Marketing pathway: 510(K)

FDA classification definition

Human immunodeficiency virus (HIV) Point of Care serological diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV antigen(s) and/or detection of antibodies against HIV 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: QSU

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