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immunoassay systems
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Aligned to Help Move Reproductive Health Management Forward
Jan 16, 2014Aligned 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), ...
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The Cardiac Disease Management Assay Was Approved by FDA 510(K) for The Beckman Coulter
Sep 29, 2013Beckman 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
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Abbott Has Received CE Mark Approval for Architect Hba1c Assay
Jul 11, 2012Abbott 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
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FDA Grants PMA to Beckman Coulter's Simple, Non-Invasive PHI Blood Test
Jun 26, 2012The 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
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