FDA product code DAM: Hemoglobin, Chain Specific, Antigen, Antiserum, Control
DAM is the FDA product code for hemoglobin, chain specific, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5470 and reviewed by the Immunology panel. Devices under DAM reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Hemoglobin, Chain Specific, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5470 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Recalls for DAM devices
openFDA lists no recalls for product code DAM.
Frequently asked questions
What is FDA product code DAM?
DAM is the FDA product code for hemoglobin, chain specific, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5470 and reviewed by the Immunology panel.
What device class is DAM?
Class II, regulation 21 CFR 866.5470. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code DAM
- Run a recall and safety report across every DAM manufacturer
- Watch product code DAM 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.