Biomerica has received CE-marking for its food intolerance tests tailored for ulcerative colitis and Crohn's disease, under the EU's IVDR.

AliveDx has obtained a CE mark under the EU's in vitro diagnostic regulation (IVDR) for the AiPlex connective tissue disease (CTDplus) multiplex assay for use with its MosaiQ planar microarray ...

One of the main challenges of transitioning from CE-IVD products to IVDR is aligning with the everchanging clinical guidelines for diagnostic devices. Under IVDR, manufacturers must generate a ...

The tests identify specific foods that may trigger inflammation in patients with Crohn's disease and ulcerative colitis.

Biomerica secures IVDR (In Vitro Diagnostic Regulation) certification, ensuring compliance with stringent European Union ...

IVDR certification positions Biomerica favorably ... products for Crohn’s Disease and Ulcerative Colitis have achieved CE-marking under the European Union’s new In Vitro Diagnostic Medical ...

Qlucore introduces the first CE-marked diagnostic test for pediatric leukemia according to the mandatory regulatory framework in Europe (IVDR). Now available for delivery and clinical use, Qlucore ...

The three diagnostic tests for identifying genetic mutations associated with SMA met new European Union regulatory ...

The firm's Anti-Measles Virus ELISA 2.0 (IgG) is used with dried blood spot samples to identify infections and determine patients' immune status.

Significant Milestone: Biomerica secures IVDR (In Vitro Diagnostic Regulation ... s Disease and Ulcerative Colitis have achieved CE-marking under the European Union’s new In Vitro Diagnostic ...