SPOT-it TREC & KREC Screening Kit

Primary DI

47350134361180

Basic UDI-DI Code

B-47350134361180

Reference

12-2015-TK

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

ImmunoIVD AB

SPOT-it™ TREC & KREC Screening Kit is a non-automated in vitro diagnostic kit intended for simultaneous screening for severe combined immunodeficiency (SCID) and agammaglobulinemia (XLA) in newborns. SCID and XLA screenings are performed by semi-quantification of T-cell receptor excision circle (TREC) and kappa-deleting recombination excision circles (KREC). 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- or T- and B-lymphocytes or XLA caused by a selective lack of mature B-lymphocytes. 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).