News & Events

FDA Grants Diazyme 510(k) Clearance to Market Its 1,5 AG Assay for Clinical Chemistry Analyzers

5th Nov 2018

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. Diazyme's 1,5 AG assay provides a fully automated two reagent assay for use on validated clinical chemistry analyzers. "Diazyme's 1,5-AG assay is a universal fully automated test that is specifically designed for us …
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Highlighted Study: Circulating Vitamin D and Colorectal Cancer Risk: An International Pooling Project of 17 Cohorts

19th Jun 2018

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, ap …
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FDA Grants Diazyme 510(k) Clearance to Market Its New EZ Vitamin D Assay for Clinical Chemistry Analyzers

22nd Jan 2018

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. Diazyme's two reagent EZ Vitamin D assay provides the only fully automated two reagent Vitamin D test for use on validated clinical chemistry analyzers. . "Diazyme's EZ Vitamin …
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FDA Grants Diazyme 510(k) Clearance to Market Its Procalcitonin Assay for Clinical Chemistry Analyzers

25th Apr 2017

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. Procalcitonin, a propeptide synthesized in the C-cells of the thyroid, has been identified to be more clinically useful and superior than currently used common clinical variables and laboratory tests in th …
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