| Device |
covid-19 test home collection kit devices |
| Definition |
Specimens collected using the Home Collection Kit can be transported at ambient temperature for testing at a laboratory. SARS-CoV-2 RNA from the clinical specimen is maintained in the specimen packaging and suitable for use in diagnostic testing preformed using a molecular in vitro diagnostic (IVD) test for the detection of SARS-CoV-2 RNA that is authorized for use with the COVID-19 Test Home Collection Kit. |
| Physical State |
Specimen collection device, swab and/or tube, stabilizing reagents. |
| Technical Method |
Collection and maintenance of nucleic acid from SARS-CoV-2 in clinical specimens |
| Target Area |
The device is a specimen collection device; none of the body parts will utilize the device or are intended to be affected by the device. |
| Review Panel |
Microbiology |
|---|
| Product Code | QLW |
|---|
| 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 |
