Device |
hiv self-tests |
Definition |
Human immunodeficiency virus (HIV) self-tests are intended for use by an individual to test themselves for the presence of HIV in body fluids. |
Physical State |
Lateral flow, membrane, manual, automated reader, swab, lancet, capillary |
Technical Method |
Antibody/antigen, elisa, chemiluminescence, manual, NAT |
Target Area |
Whole blood, plasma, serum, oral fluid, capillary blood |
Review Panel |
Microbiology |
Product Code | QSS |
Premarket Review |
Center for Biologics Evaluation & Research (CBER)
|
Submission Type |
PMA
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|