Device typeColorectal cancer genotyping IVD, kit, nucleic acid technique (NAT): A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to determine multiple genotypes associated with colorectal cancer, which may include BRAF, KRAS, APC, NRAS, PIK3CA, and/or CTNNB1 gene mutations, using a nucleic acid technique (NAT). It may be used to select treatment options and/or monitor the response to cancer therapy.
FDA categoryNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Device ID00860001218282
Catalog numberHDA-LC-2001-4
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information