IntRaFast-Q SMA SCREENING KIT

Primary DI

D-86804222814035R

Basic UDI-DI Code

B-86804222814035R

Reference

200R-40-01

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

SNP BİYOTEKNOLOJİ ARAŞTIRMA GELİŞTİRME VE ÜRETİM SANAYİ VE TİCARET LİMİTED ŞİRKETİLİMİTED

Spinal muscular atrophy (SMA) is characterized by degeneration of the alpha motor neurons of the spinal cord anterior horn cells, leading to progressive proximal muscle weakness and atrophy. The carrier frequency of SMA from 1/20 to 1/60. IntRaFast-Q SMA Screening Kit detects the Exon 7 and Exon 8 deletion and C/T substitution at nucleotide 840 of Exon 7 in the SMN1 gene to diagnose the carrier and homozygous types by Quantitative Real Time PCR (qPCR) from blood samples. The kit has % 100 sensitivity and % 100 specificity for the detection of above mentioned targets in homozygous and carrier types.

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