Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
QWB is the FDA product code for Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens, a class II device type, regulated under 21 CFR 866.3984. FDA's definition for this code reads: "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...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- QWB
- Device name
- Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
- FDA 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.
- Regulation
- 21 CFR 866.3984
- Device class
- Class II
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 3
- Ingested recalls
- 1
Clearances, product code QWB
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2023 | 2 |
| 2026 | 1 |
Applicants with the most clearances
Product code QWB| Applicant | Clearances |
|---|---|
| Cue Health, Inc. | 2 |
| Aptitude Medical Systems | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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