NeoNat SCID-SMA Real-Time PCR Kit

Primary DI

06438172311015

Basic UDI-DI Code

B-06438172311015

Reference

8100481

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Labsystems Diagnostics Oy

Labsystems Diagnostics’ NeoNat SCID-SMA Real-Time PCR Kit is a Real-Time PCR kit for the screening of Severe Combined Immunodeficiency (SCID) by semi quantitative determination of TREC (T-cell Receptor Excision Circle), & KREC (Kappa-deleting Recombination Excision Circle), Spinal Muscular Atrophy (SMA) by measuring SMN1 (Survival Motor Neuron 1), & SMN2 (Survival Motor Neuron 2) and X-linked agammaglobulinemia (XLA) in newborn’s DNA extracted from DBS samples. This assay should only be used in conjunction with other clinical and confirmatory laboratory findings and results from this test alone should not be used to make diagnostic or treatment decisions. 96 reactions package

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