SIA
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3984
- Medical specialty
- Microbiology
- FDA definition
- 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| Visby Medical Flu and COVID-19 Test (K253971) | Visby Medical, Inc. | 2026-05-27 | + Add |
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