FDA product code MYR: Test, Donor, Syphilis, Antigens, Treponemal
MYR is the FDA product code for test, donor, syphilis, antigens, treponemal. It is a Class II device, regulated under 21 CFR 866.3830 and reviewed by the Immunology panel. Devices under MYR reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Test, Donor, Syphilis, Antigens, Treponemal |
| Device class | Class II |
| Regulation | 21 CFR 866.3830 |
| Review panel | IM — Immunology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Recalls for MYR devices
openFDA lists no recalls for product code MYR.
Frequently asked questions
What is FDA product code MYR?
MYR is the FDA product code for test, donor, syphilis, antigens, treponemal. It is a Class II device, regulated under 21 CFR 866.3830 and reviewed by the Immunology panel.
What device class is MYR?
Class II, regulation 21 CFR 866.3830. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code MYR
- Run a recall and safety report across every MYR manufacturer
- Watch product code MYR 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.