QWB — Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens Class II
Classification Details
- Product Code
- QWB
- Device Class
- Class II
- Regulation Number
- 866.3984
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
An over-the-counter molecular test to detect SARS-CoV-2 is an in vitro diagnostic device for the detection of SARS-CoV-2 in clinical specimens to aid in the diagnosis of SARS-CoV-2 infection. The device is intended to be used by lay users and without health care provider (HCP) intervention in home settings or similar environments.