News & Media

SAN DIEGO, CA – 5 November 2018 – Diazyme Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(K) clearance to market its 1,5 AG assay.

SAN DIEGO, CA – (June 19, 2018) In a recent study, It was found that circulating Vitamin D Could Lower Risk Of Colorectal Cancer.“Higher circulating 25(OH)D was related to a statistically significant, substantially lower colorectal cancer risk in women and non–statistically significant lower risk in men. Optimal 25(OH)D concentrations for colorectal cancer risk reduction, 75-100 nmol/L, appear higher than current IOM recommendations.” according to a study published i...

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...