IVDR
Medicover Genetics Receives IVDR Certification for Genetic Testing Reagent Kit
The TarCET Kit offers a suite of sequencing panels covering a range of genetic conditions including metabolic disorders, infertility, and cardiovascular diseases.
Devyser Fetal RHD Screening Test Receives IVDR Certification
The qPCR-based test can help determine the rhesus D antigen status of the fetus in a pregnant woman.
Yourgene Health Cystic Fibrosis Assay Receives IVDR Certification
The assay uses amplification-refractory mutation system (ARMS) technology and genetic analyzers to detect the 50 most common CF mutations in European ancestry populations.
Qiagen Gets CE-IVDR Certification for QiaStat-Dx Instruments, Assays
The German molecular diagnostics and reagents firm said it has converted more than 80 percent of a planned total of 180 products to the new IVDR regulatory framework.
Adaptive Biotechnologies Gets IVDR Class C Certification for ClonoSeq Assay
The certification makes the ClonoSeq assay available to EU patients and enables Adaptive to process EU clinical trial samples in its US laboratory.