News & Media

  • FDA Grants Diazyme 510(k) Clearance to Market Its Direct HbA1c (Enzymatic, On-Board Lysis) Assay for Clinical Chemistry Analyzers

    SAN DIEGO, CA – 28 November 2016 – Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market its Direct HbA1c assay (Enzymatic, On-Board Lysis).  HbA1c refers to glycated hemoglobin which occurs when hemoglobin, a protein within red blood cells that transports oxygen through the body, joins with glucose in the blood, thereby becoming glycated. Measuring HbA1c allows clinicians to get an overall picture of wh...

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

    SAN DIEGO, CA – (Nov 21, 2016) – Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearances to market its two B vitamin assays, Vitamin B12 and Folate assays. Vitamin B12 and Folate perform several important functions in the body.

  • Diazyme Prevails in Maintaining Its Right to Distribute Its Procalcitonin (PCT) Test in Germany

    SAN DIEGO, CALIFORNIA, U.S.A., 6 SEPTEMBER 2016 – Diazyme Laboratories announces that it will continue to distribute its procalcitonin (PCT) test in Germany through its German subsidiary Diazyme Europe. This follows the lifting by the district court of Munich on August 31, 2016 of a preliminary injunction obtained by B.R.A.H.M.S. GmbH (BRAHMS) on July 13, 2016 based on alleged infringement of BRAHMS's European PCT patent EP 2 028 493 B1.PCT is a marker for diagnosis of sepsis, and the Diazyme PC...

  • New Study Shows That Four Biomarkers, Including Homocysteine, May Help to Predict the Risk of Stroke

    SAN DIEGO, CA – (August 25, 2016)  In a recent study, multiple biomarkers were examined to see the relationship between them and stroke."People with high levels of four biomarkers in the blood may be more likely to develop a stroke than people with low levels of the biomarkers, according to a study published in the August 24, 2016, online issue of Neurology, the medical journal of the American Academy of Neurology.""Of the 15 biomarkers, four were associated with an inc...

  • Diazyme is Excited to Now Offer the Diadexus PLAC® Assays

    SAN DIEGO, CA – (August 1, 2016) - Diazyme Laboratories today announced that it has purchased substantially all of the assets of Diadexus, Inc. (Diadexus), including all intellectual property. Diazyme is excited to now offer the Diadexus PLAC® assays."Adding the PLAC assays to Diazyme’s already comprehensive diagnostic testing for heart disease demonstrates Diazyme’s commitment to providing complete clinical diagnostic solutions to doctors and patients” said Dr.

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