For in vitro diagnostic use. Others LightMix Newborn TREC/SMN1/HBB IVD LightMix® Newborn TREC/SMN1/HBB 100 1377683945183 This product is not a Roche product, Roche Global Customer Support is not offering any Support. For any additional information and support please ONLY contact TIB MolBiol directly. Furthermore we can not guarantee that all available information for this product is up to date. PID00001424 Real-time PCR kit for detection of TREC, SMN1 and HBB The product 40-0621-IVD is a kit used for the in-vitro examination of DNA extracts from dried blood spots to provide information by screening for the following mutations and respective diseases in newborns:(1) the absence of T-cell receptor excision circles (TREC), a sign for severecombined immunodeficiency disease (SCID) or other TREC associated syndrome-based immunodeficiencies,(2) homozygous deletions of survival motor neuron 1 (SMN1) exon 7, thepredominant cause for severe type 1 spinal muscular atrophy (SMA), and(3) for mutations in the region of codon 6 of the beta globin gene (HBB), commonlyassociated with sickle cell disease (SCD) and selected forms of beta-thalassemia caused by alterations in this gene region.The IVD medical device detects human DNA of newborns from nucleic acid extractby qualitative measurement based on real-time PCR and is intended for manual use by professional laboratory personnel in a diagnostic laboratory. It must be used incombination with the MagNA Pure 96 or MagNA Pure 24 System for DNA extraction,the LightCycler® PRO Instrument including LightCycler® PRO Instrument Softwareand the LightCycler® Multiplex DNA Master. en

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LightMix^® Newborn TREC/SMN1/HBB

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