PAN — Braf Mutation Kit Class N
FDA product code PAN covers "Braf Mutation Kit", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- PAN
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Unknown
- Implant
- No
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.