Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
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.
PixCell Medical's CBC Analyzer Receives IVDR Certification
The HemoScreen instrument is a point-of-care five-part differential complete blood count analyzer that is used for rapid testing from a drop of blood.
Qiagen QiAcuityDx Digital PCR System Gets Regulatory Clearance in Australia, New Zealand
The system is currently available with research-use assays, and the firm expects to launch precision cancer tests in the future.
Called the Coalition for Effective Diagnostics, the organization has called on lawmakers to pass legislation revamping diagnostics regulation, including oversight of LDTs.