QLW · Covid-19 Test Home Collection Kit Devices
· Class N
Overview
| Product Code | QLW |
|---|---|
| Device Name | Covid-19 Test Home Collection Kit Devices |
| Device Class | Class N |
| Review Panel |
Identification
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
