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Braf Mutation Kit

PAN · Not classified · Unknown

Classification

FDA Product Code
PAN
Device class
Not classified
Regulation
Review panel
PA
Medical specialty
Unknown
Submission type
3
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

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.

Market data

Cleared 510(k) submissions
0
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
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