SIA · Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test
Microbiology · 21 CFR 866.3984 · Class 2
Overview
| Product Code | SIA |
|---|---|
| Device Name | Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test |
| Regulation | 21 CFR 866.3984 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
An over-the-counter molecular multi-analyte respiratory virus detection test is an in vitro diagnostic device for the detection and/or differentiation of respiratory viruses directly from clinical specimens. The device is intended to be used by lay users and without health care provider (HCP) intervention in home settings or similar environments.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253971 | Visby Medical Flu and COVID-19 Test | Visby Medical, Inc. | May 27, 2026 | SESE |
Top Applicants
- Visby Medical, Inc. — 1 clearance
