QSV — Point Of Care Hiv Nat Diagnostic And/Or Supplemental Test Class II
FDA product code QSV covers "Point Of Care 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
- QSV
- Device Class
- Class II
- Regulation Number
- 866.3957
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
Human immunodeficiency virus (HIV) Point of Care nucleic acid diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV nucleic acid in human body fluids or tissues.