FDA product code PDF: Immunoglobulin M Lambda Heavy And Light Chain Combined
PDF is the FDA product code for immunoglobulin m lambda heavy and light chain combined. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel. Devices under PDF reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Intended for the in-vitro quantification of IgM lambda concentration in human serum. The result is to be used with previously diagnosed IgM Waldenstoms Macrolobulinaemia, in conjunction with other clinical and laboratory findings.
Classification
| Field | Value |
|---|---|
| Device name | Immunoglobulin M Lambda Heavy And Light Chain Combined |
| Device class | Class II |
| Regulation | 21 CFR 866.5510 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for PDF devices
openFDA lists no recalls for product code PDF.
Frequently asked questions
What is FDA product code PDF?
PDF is the FDA product code for immunoglobulin m lambda heavy and light chain combined. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel.
What device class is PDF?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PDF
- Run a recall and safety report across every PDF manufacturer
- Watch product code PDF 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.