SIA — Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test Class II
FDA product code SIA covers "Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test", a Class II medical device regulated under 21 CFR 866.3984. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SIA
- Device Class
- Class II
- Regulation Number
- 866.3984
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253971 | visby medical | Visby Medical Flu and COVID-19 Test | May 27, 2026 |