FRAGILE X SYNDROME

Primary DI

D-00106010104013V8

Basic UDI-DI Code

B-00106010104013V8

Reference

50 Tests/Kit

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Beijing Healthgene Laboratory Co.,Ltd

This kit is mainly used for the detection of FMR1 gene mutation (CGG repeat number) in human EDTA anticoagulated whole blood samples in vitro.At present, the American College of Medical Genetics (ACMG) divides the FMR1 gene into four genotypes according to the number of CGG repeats: CGG repeats ≤44 are "unaffected" or "wild type"; The interval is "intermediate" or "gray zone"; the interval between 55-200 is "pre-mutation"; when it is above 200, it is "full mutation". FMR1 gene mutation causes fragile X syndrome.

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