Device |
over-the-counter covid-19 antigen test |
Definition |
For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older. |
Physical State |
Solid phase test device/dip-stick |
Technical Method |
Lateral flow Immunochromatographic Assay |
Target Area |
Anterior Nasal Swabs |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | QYT |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
Submission Type |
510(k)
|
Regulation Number |
866.3984
|
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 |