Device |
point of care hiv serology diagnostic and/or supplemental test |
Regulation Description |
Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test. |
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. |
Physical State |
Lateral flow, membrane, manual, automated reader, swab, lancet, capillary |
Technical Method |
Antibody/antigen, elisa, chemiluminescence, manual |
Target Area |
Whole blood, plasma, serum, oral fluid, capillary blood, venous blood |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | QSU |
Premarket Review |
Center for Biologics Evaluation & Research (CBER)
|
Submission Type |
510(k)
|
Regulation Number |
866.3956
|
Device Class |
2
|
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 |
|
|