News & Media

  • 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...

  • Diazyme Receives 510(k) FDA Clearance for Enzymatic Glycated Serum Protein (Glycated Albumin) Assay Kit

    FOR IMMEDIATE RELEASEMay 25, 2011SAN DIEGO, CA--(Marketwire - May 24, 2011) - Diazyme Laboratories announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k) clearance to market its Enzymatic Glycated Serum Protein (GSP, Glycated Albumin) Assay Kit.Recent studies have shown that blood HbA1c levels alone may not accurately reflect serum glucose concentrations in all diabetic patients. The difference between the actual measured HbA1c concentration and the predicted...

  • Diazyme Receives FDA 510(k) Clearance for Vitamin D Assay

    FOR IMMEDIATE RELEASE Jan 24, 2011 SAN DIEGO, CA--(Marketwire - January 24, 2011) - Diazyme Laboratories announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k) clearance to market its 25-Hydroxy Vitamin D assay. Diazyme's 25-Hydroxy Vitamin D test is an innovative homogenous assay which measures the true total 25-Hydroxy Vitamin D (sum of both D3 + D2).

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