Aligned with its commitment to help move reproductive health management forward, Beckman Coulter Diagnostics has received clearance for its new Access Total βhCG (5th IS) assay from the U.S. Food and Drug Administration (FDA) 510(k), ...
Beckman Coulter, a manufacturer of biomedical laboratory instruments, has obtained the 510(k) approval from the US Food and Drug Administration (FDA) for its Access AccuTnI+3 troponin I assay for use on the UniCel DxI series of immunoassay ...
Tags: Beckman Coulter, Cardiac Disease
Abbott has received CE mark approval for Architect HbA1c assay, designed to monitor treatment efficacy for diabetes patients. The chemiluminescent microparticle Architect HbA1c assay, which is designed for the quantitative determination ...
Tags: Architect HbA1c assay, Architect i immunoassay systems
The US Food and Drug Administration (FDA) has granted premarket approval (PMA) to Beckman Coulter's simple, non-invasive Prostate Health Index (phi) blood test. The phi test, indicated for use in men with a prostate-specific antigen (PSA) ...
Tags: phi blood test, Prostate Health Index Test, immunoassay systems