Diazyme Laboratories, Inc. Announces Availability of COVID-19 Antibody Tests
23rd Mar 2020
SAN DIEGO, CA – (March 23, 2020)
Diazyme announces the availability of two serological tests for the novel coronavirus (SARS-CoV-2), namely the Diazyme DZ-Lite SARS-CoV-2 IgG and SARS-CoV-2 IgM CLIA test kits. The Diazyme IgG and IgM tests are run on the fully automated Diazyme DZ-Lite 3000 Plus chemiluminescence analyzer. The Diazyme serological test notification is now listed on FDA’s EUA webs
…
Highlighted Study: Verification of FDA-Cleared Kappa and Lambda Free Light Chain Assays on the Beckman Coulter DxC 800
14th Nov 2019
SAN DIEGO, CA – (November 14, 2019) In a newly published study, Diazyme’s Kappa and Lambda Free Light Chain Assay performance was verified on the Beckman Coulter DxC 800.
“We conclude the Diazyme κ and λ FLC assays when run on the Beckman-Coulter DxC analyzer exhibit excellent precision and accuracy, and are comparable to the Freelite assays on the Roche Cobas Integra analyzer”.
Click below to
…
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
…
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
…
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
…