← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · UNCLASSIFIED

PAN — Braf Mutation Kit

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.

DEVICE CLASS
Unclassified
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
PA
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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