QST — Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test Class II
FDA product code QST covers "Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test", a Class II medical device regulated under 21 CFR 866.3957. Submissions are reviewed by the Microbiology panel.
Classification Details
- Product Code
- QST
- Device Class
- Class II
- Regulation Number
- 866.3957
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.