Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
Sysmex Gets Approval in Japan for Retinal Dystrophy Gene Panel
The next-generation sequencing panel identifies genetic mutations that cause inherited retinal dystrophy, which results in vision problems, including blindness.
Euroimmun Nabs CE Mark for Indirect Immunofluorescence Test Instrument
The firm said it is launching sales in countries that accept CE marking of its Uniqo 160 automated indirect immunofluorescence test instrument.
The agency is cross-training employees to add surge capacity in response to shifting demand and is helping develop a pending national testing plan.
Cepheid Nabs CE-IVD Mark for Molecular NPM1 Mutation Test for AML Monitoring
The test quantifies mutant NPM1 mRNA transcripts in peripheral blood specimens from patients with acute myeloid leukemia.
BioTeke Nabs FDA EUA for COVID-19 Rapid Antigen Test
The Bio-Self COVID-19 Antigen Home Test is a lateral flow immunoassay that uses nasal swab samples and delivers results in 15 minutes.