SPOT-it TREC & SMN1 Screening Kit

Primary DI

37350134361787

Basic UDI-DI Code

B-37350134361787

Reference

4-2020-TS

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

ImmunoIVD AB

SPOT-it™ TREC & SMN1 Screening Kit is a non-automated in vitro diagnostic kit intended for simultaneous screening for severe combined immunodeficiency (SCID) and Spinal Muscular Atrophy (SMA) in newborns. SCID screening is performed by semiquantification of T-cell receptor excision circle (TREC) and SMA screening by a qualitative detection of exon 7 of the SMN1 gene. DNA is extracted from fresh, dried blood spots (DBS) sampled on filter paper. The principle of the assay is real-time quantitative polymerase chain reaction (qPCR). The test is intended for use by laboratory professionals to aid in identifying newborns who potentially suffer from SCID caused by a lack of mature T-lymphocytes or SMA caused by homozygous exon 7 deletion in the SMN1 gene. Diagnosis shall be made by healthcare professionals through confirmatory testing, according to local requirements or recommendations.

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