News & Media

SAN DIEGO, CA – 22 January 2018 – Diazyme Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(K) clearance to market its EZ Vitamin D assay for Clinical Chemistry Analyzers.

SAN DIEGO, CA – 25 April 2017 – Diazyme Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market its Procalcitonin (PCT) assay.

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...

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.

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...