Human B Lymphocyte Minimal Residual Disease Detection Kit

Dénomination commerciale

Human B Lymphocyte Minimal Residual Disease Detection Kit

Code d'IUD-ID

06975029660389

IUD-ID de base

B-06975029660389

Numéro de référence/catalogue

RSN040

Entité d'attribution

GS1

Catégorie de risque

IVDD — Général

Législation applicable

IVDD [Directive 98/79/CE relative aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The Kit is an in vitro diagnostic (IVD) assay for the detection of clonal rearrangements and somatic hypermutation (SHM) in B-cell receptor (BCR) genes via next-generation sequencing (NGS). It detects rearrangements in the CDR3 regions of IgH (VDJ), IgK, and IgL, as well as translocated BCL1/IgH and BCL2/IgH sequences, along with somatic hypermutation (SHM) in the IGHV variable region. The kit is intended for use with genomic DNA(gDNA) isolated from pre- and post-treatment bone marrow samples of patients with B-cell acute lymphoblastic leukemia (ALL) and multiple myeloma (MM), and bone marrow or peripheral blood samples of patients with chronic lymphocytic leukemia (CLL). This assay enables minimal residual disease (MRD) assessment by identifying patient-specific Ig clonal rearrangements and SHM patterns in baseline samples and monitoring their presence in MRD samples.

URL des informations complémentaires

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Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• W01060299TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.