FDA product code PAN: Braf Mutation Kit
PAN is the FDA product code for braf mutation kit. It is a Not classified device, reviewed by the Pathology panel. Devices under PAN reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
The BRAF mutation kit is a multiplex qualitative in vitro diagnostic device to identify specific BRAF mutations by multiplex polymerase chain reaction of genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) colorectal cancer or fine needle aspirated (FNA) thyroid tissue. It is intended to aid in the treatment decisions and risk stratification of patients diagnosed with colorectal or papillary thyroid cancer.
Classification
| Field | Value |
|---|---|
| Device name | Braf Mutation Kit |
| Device class | Not classified |
| Review panel | PA — Pathology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for PAN devices
openFDA lists no recalls for product code PAN.
Frequently asked questions
What is FDA product code PAN?
PAN is the FDA product code for braf mutation kit. It is a Not classified device, reviewed by the Pathology panel.
What device class is PAN?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code PAN
- Run a recall and safety report across every PAN manufacturer
- Watch product code PAN 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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