| Device |
covid-19 multi-analyte antigen device |
| Definition |
A COVID-19 Multi-Analyte Antigen Device is a test for the qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and common respiratory microorganisms in human respiratory and/or acceptable clinical specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 by a healthcare provider. Results should not be interpreted in the context of clinical observations, patient history, and/or epidemiological information, patient history, and/or epidemiological information. |
| Physical State |
Antigen detection reagent kit |
| Technical Method |
Immunoassay |
| Target Area |
The device is an in-vitro diagnostic device; none of the body parts will utilize the device or are intended to be affected by the device. |
| Review Panel |
Microbiology |
|---|
| Product Code | QMN |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
|
Not Classified Reason
|
EUA - Emergency Use Authorization
|
|---|
| Submission Type |
EUA - Emergency Use Authorization
|
|---|
| Device Class |
Not Classified
|
| 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 |
