BRCA1/2 Gene Mutations Detection Kit (High Throughput Sequencing)

Primary DI

06972665700103

Basic UDI-DI Code

B-06972665700103

Reference

Lotus NL B.V. Address：Koningin Julianaplein 10,1e Verd,2595AA,The Hague, Netherlands. Email：[email protected]

Device Types

Single use Sterilization

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

XIAMEN SPACEGEN CO.,LTD.

This kit is used to qualitatively detect the mutation status of BRCA1/2 gene in paraffin tissue samples of patients with breast or ovarian cancer, the detection range covers BRCA1 gene and 2229 somatic mutations in all exons of BRCA2 gene. The test results are only used for clinical auxiliary diagnosis， should not be used as the sole basis for individualized treatment of breast or ovarian cancer patients.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).