CHROMOSOMAL DISORDERS TESTS - OTHER

Primary DI

06974944990014

Basic UDI-DI Code

B-06974944990014

Reference

BCR-ABL1(p210) %IS Kit (Digital PCR Method)

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Suzhou Sniper Medical Technologies Co., Ltd.

This kit is used to quantify ribonucleic acid (RNA) of fusion gene BCR-ABL1 (p210) and ABL1 in peripheral blood of patients with chronic myeloid leukemia (CML); By calculating the ratio of BCR-ABL1 to ABL1 copy number and converting to International Scale percent ratio (% IS), the report is expressed as Molecular Reduction level (MR).

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