Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test
SIA is the FDA product code for Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test, a class II device type, regulated under 21 CFR 866.3984. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SIA
- Device name
- Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test
- 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.
- Regulation
- 21 CFR 866.3984
- Device class
- Class II
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code SIA
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2026 | 1 |
Applicants with the most clearances
Product code SIA| Applicant | Clearances |
|---|---|
| Visby Medical, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code SIA.
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