Eu Ivdd Eu Ivd General On The Market 🇨🇳 China

Chromosomal Copy Number Variation Testing Kit (Single Molecule Direct Sequencing)

GeneMind Biosciences Co., Ltd. · 🇨🇳 China
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
06974968583148
Basic UDI-DI Code
B-06974968583148
Reference
L000023
Device Types
None provided
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market

Additional Description

The incidence of birth defects in my country is about 5.6%, and there are about 900,000 new birth defects every year, and chromosomal aberrations account for more than 80% of the hereditary causes of birth defects. Up to now, more than 300 chromosomal microdeletion/microduplication syndromes caused by pathogenic chromosomal copy number variations (pCNVs) have been identified, with a combined incidence of nearly 1/600, accounting for half of birth defects caused by chromosomal aberrations. Therefore, timely and accurate prenatal diagnosis of chromosomal aberrations is conducive to further reducing the birth defect rate and disability rate of live births, and is of great significance to the prevention and control of birth defects.

CND Nomenclature Codes

Code Description
W0106010399 CHROMOSOMAL DISORDERS TESTS - OTHER

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