FDA product code PHF: Zinc Transporter 8 Auto-Antibody
PHF is the FDA product code for zinc transporter 8 auto-antibody. It is a Class II device, regulated under 21 CFR 866.5670 and reviewed by the Immunology panel. Devices under PHF reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
The Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay is for the semi-quantitative determination of autoantibodies to Zinc Transporter 8 (ZnT8) in human serum. The Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay may be useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes). The ZnT8Ab assay is not to be used alone and is to be used in conjunction with other clinical and laboratory findings.
Classification
| Field | Value |
|---|---|
| Device name | Zinc Transporter 8 Auto-Antibody |
| Device class | Class II |
| Regulation | 21 CFR 866.5670 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for PHF devices
openFDA lists no recalls for product code PHF.
Frequently asked questions
What is FDA product code PHF?
PHF is the FDA product code for zinc transporter 8 auto-antibody. It is a Class II device, regulated under 21 CFR 866.5670 and reviewed by the Immunology panel.
What device class is PHF?
Class II, regulation 21 CFR 866.5670. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PHF
- Run a recall and safety report across every PHF manufacturer
- Watch product code PHF 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.
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