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QSTClass II

Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test

21 CFR 866.3957 / Microbiology
FDA source (opens on fda.gov)

QST is the FDA product code for Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test, a class II device type, regulated under 21 CFR 866.3957. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QST
Device name
Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test
FDA 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.
Regulation
21 CFR 866.3957
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