PAN

Braf Mutation Kit

Product code: PAN
Device name: Braf Mutation Kit
Device class: Class N
Medical specialty: Unknown
Marketing pathway: Contact ODE

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: PAN

Classification and pathway per current FDA publications. Data from openFDA (CC0).