FDA product code SER: Immunohistochemistry Assay, Antibody, Met
SER is the FDA product code for immunohistochemistry assay, antibody, met. It is a Class III device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel. Devices under SER reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
The MET antibody is a qualitative immunohistochemical antibody intended to identify MET protein expression in human clinical tissue specimens. The MET antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.
Classification
| Field | Value |
|---|---|
| Device name | Immunohistochemistry Assay, Antibody, Met |
| Device class | Class III |
| Regulation | 21 CFR 864.1860 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | PMA |
Recalls for SER devices
openFDA lists no recalls for product code SER.
Frequently asked questions
What is FDA product code SER?
SER is the FDA product code for immunohistochemistry assay, antibody, met. It is a Class III device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel.
What device class is SER?
Class III, regulation 21 CFR 864.1860. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code SER
- Run a recall and safety report across every SER manufacturer
- Watch product code SER 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.