FDA product code SIA: 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. It is a Class II device, regulated under 21 CFR 866.3984 and reviewed by the Microbiology panel. Devices under SIA reach the market by 510(k); FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test |
| Device class | Class II |
| Regulation | 21 CFR 866.3984 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Recalls for SIA devices
openFDA lists no recalls for product code SIA.
Frequently asked questions
What is FDA product code SIA?
SIA is the FDA product code for over-the-counter molecular multi-analyte respiratory virus detection test. It is a Class II device, regulated under 21 CFR 866.3984 and reviewed by the Microbiology panel.
What device class is SIA?
Class II, regulation 21 CFR 866.3984. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SIA
- Run a recall and safety report across every SIA manufacturer
- Watch product code SIA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.