QLW — Covid-19 Test Home Collection Kit Devices Class N
FDA product code QLW covers "Covid-19 Test Home Collection Kit Devices", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QLW
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Unknown
- Implant
- No
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.