QSU — Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test Class II
FDA product code QSU covers "Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test", a Class II medical device regulated under 21 CFR 866.3956. Submissions are reviewed by the Microbiology panel.
Classification Details
- Product Code
- QSU
- Device Class
- Class II
- Regulation Number
- 866.3956
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.