SBY

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids

Device class

Class II (moderate risk)

Regulation

21 CFR 866.6085

Medical specialty

Pathology

FDA definition

A high throughput sequencing based tumor profiling test of circulating cell-free nucleic acids is a qualitative in vitro diagnostic test intended for next generation sequencing analysis of circulating cell-free nucleic acids from plasma samples collected from peripheral whole blood to detect mutations in a panel of targeted genes to aid in the management of previously diagnosed cancer patients by qualified health care professionals. The results of the test are not prescriptive or conclusive for use of any specific therapeutic product.

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