News & Media

  • FDA Grants Diazyme 510(k) Clearance to Market Its Vitamin D Assay for Clinical Chemistry Analyzers

    SAN DIEGO, CA–(Marketwire – Mar 24, 2014) – Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(K) clearance to market its Vitamin D assay for Clinical Chemistry Analyzers. In line with the rapid increasing clinical demands for testing of this important biomarker, Diazyme's new Vitamin D assay, utilizing its femtoquantTM  technology (a sensitive homogenous enzyme-immunoassay platform), provides the first fully automated Vitamin D test for us...

  • FDA Grants Diazyme 510(k) Clearance to Market Its Myoglobin Assay for Clinical Chemistry Analyzers

    SAN DIEGO, CA--(Marketwired - Jul 24, 2013) - Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market its Myoglobin assay. In line with current clinical needs, Diazyme's Myoglobin latex-enhanced immunoturbidimetric assay can be utilized to measure Myoglobin in serum and plasma samples as an aid in the diagnosis of acute myocardial infarction.

  • FDA Grants Diazyme 510(k) Clearance to Market Its D-Dimer Assay for Clinical Chemistry Analyzers

    SAN DIEGO, CA--(Marketwire - Feb 12, 2013) - Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market its D-Dimer assay. In line with current clinical needs, Diazyme's D-Dimer latex-enhanced immunoturbidimetric assay can be utilized to measure total levels of D-Dimer in plasma samples as part of a work up of patients with blood clotting issues.

  • FDA Grants Diazyme 510(k) Clearance to Market its New 25-Hydroxy Vitamin D Enzyme Immunoassay

    SAN DIEGO, CA--(Marketwire--January 7th 2013) - Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market its new 25-Hydroxy Vitamin D assay.  In line with current clinical needs, Diazyme’s new 25-Hydroxy Vitamin D Assay measures total true 25-Hydroxy Vitamin D levels (D2 + D3 levels) in both serum and plasma samples. Furthermore, the assay fully automates the removal of non-specific protein binding and cross reactivity that...

  • FDA Grants Diazyme Clearance to Market a New Biomarker for Early Detection of Kidney Disease, on the SMART Point of Care System

    SAN DIEGO, CA - Nov 8, 2012 -  Diazyme Laboratories announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k) clearance to market its Cystatin C POC Test Kit on the SMART Point of Care System. The SMART Point of Care chemistry system offers a wide range of rapid testing capabilities for cardiovascular and stroke risk, diabetes monitoring and now early detection of acute and chronic kidney disease.  The Cystatin C POC Test Kit is the first to employ thi...

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