Human Endometrial Cancer Molecular Classification Detection Kit (High Throughput Sequencing)

Primary DI

06972665700257

Basic UDI-DI Code

B-06972665700257

Reference

Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[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 POLE and TP53 genes in paraffin-embedded tissue samples of endometrial cancer patients, and detect 34 microsatellite loci to analyze the microsatellite instability status of patients. The test results are only for the evaluation of molecular characteristics of endometrial cancer patients to provide clinical reference, and should not be used as the sole basis for individualized treatment of endometrial cancer. Clinicians should consider the patient's condition, drug indications, treatment response and other laboratory test indicators. and other factors to make a comprehensive judgment on the test results.

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