News & Media

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

    SAN DIEGO, CA – (Feb 24, 2016) - Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market its Fibrinogen Assay. Fibrinogen is a protein involved in the blood clotting (coagulation) process.

  • Diazyme Assays Featured in Recent Publications

    Diazyme wants to highlight some recent publications that touch on Diazyme’s PCT and Vitamin D Assays.  The first from the journal  “Expert Review of Molecular Diagnostics” is titled “First 25-hydroxyvitamin D assay for general chemistry analyzers”  which touches on Diazyme’s Vitamin D assay.  The second journal article from the journal “Clin Chem Lab Med 2014”  is titled “Analytical evaluation of Diazyme procalcitonin (PCT) latex-enhanced immunoturbidimetric assay on Bec...

  • Diazyme’s Jonathan Dedes Receives AACC Award

    On 9/18/2014, at AACC's (American Association of Clinical Chemistry) 25th International Symposium for Critical and Point of Care testing (CPOCT), Diazyme Scientist Jonathan Dedes received the prestigious award for "outstanding research in critical and point of care testing." The award was presented to Jonathan by Dr. William Clarke, the Chair, CPOCT International Symposium Planning Committee. Mr.

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

    SAN DIEGO, CA – (Marketwired - Jul 7, 2014) - Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market its Ferritin Assay. In line with current clinical needs, Diazyme's Ferritin Latex-Enhanced Immunoturbidimetric Assay can be utilized to measure levels of ferritin in serum and plasma samples as part of a work up of patients with iron deficiency issues.

  • 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...

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