21 CFR 866.3984 — Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3984
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QWB | Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens | 2 | 2 | SaMD |
| QYT | Over-The-Counter Covid-19 Antigen Test | 2 | 13 |
