← FDA Medical Device Classifications
Over-The-Counter Covid-19 Antigen Test
QYT · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3984
Classification
- FDA Product Code
QYT- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 866.3984
- Review panel
- MI
- Medical specialty
- Microbiology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.
Market data
- Cleared 510(k) submissions
- 13
- Registered establishments
- 22
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown