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QSUClass II

Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test

21 CFR 866.3956 / Microbiology
FDA source (opens on fda.gov)

QSU is the FDA product code for Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test, a class II device type, regulated under 21 CFR 866.3956. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QSU
Device name
Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test
FDA 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.
Regulation
21 CFR 866.3956
Device class
Class II
Review panel
Microbiology
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