Tag Archives: Diazyme Laboratories

July 2021—Diazyme launched its FDA 510(k)–exempt Beta-Hydroxybutyrate Assay for the quantitative determination of beta-hydroxybutyrate. BHB serves as a guide for monitoring the progress of insulin therapy for diabetic ketoacid­osis and for patients presenting to the emergency room with documented hypoglycemia, acidosis, alcohol ingestion, or an unexplained increase in the anion gap.

June 2021—Diazyme Laboratories obtained CE-IVD marking for its SARS-CoV-2 neutralizing antibody test, a high-throughput chemiluminescent immunoassay.

June 8, 2021—Diazyme launched its FDA 510(k)–exempt Beta-Hydroxybutyrate Assay for the quantitative determination of beta-hydroxybutyrate.

April 2021—Diazyme received FDA emergency use authorization for its Semi-Quantitative DZ-Lite SARS-CoV-2 IgG CLIA test, which runs on the DZ-Lite 3000 Plus chemiluminescence analyzer. The FDA granted Diazyme an EUA for its qualitative DZ-Lite SARS-CoV-2 IgG CLIA test in July and has now authorized the Diazyme IgG assay to be used as a semiquantitative test.

April 2, 2021—Diazyme Laboratories obtained CE-IVD marking for its SARS-CoV-2 neutralizing antibody test, a high-throughput chemiluminescent immunoassay.

March 26, 2021—Diazyme received FDA emergency use authorization for its Semi-Quantitative DZ-Lite SARS-CoV-2 IgG CLIA test, which runs on the DZ-Lite 3000 Plus chemiluminescence analyzer.

October 2020—Diazyme Laboratories announced it received FDA emergency use authorization for the Diazyme DZ-Lite SARS-CoV-2 IgM CLIA test. The test is highly sensitive and specific and does not cross-react with the HKU1, OC43, NL63, and 229E coronavirus strains.

September 2020—Diazyme Laboratories received FDA emergency use authorization for the Diazyme DZ-Lite SARS-CoV-2 IgG CLIA test.

Aug. 24, 2020—Diazyme Laboratories announced receiving FDA emergency use authorization for the Diazyme DZ-Lite SARS-CoV-2 IgM CLIA test.

Aug. 5, 2020—Diazyme announced a partnership with Maccura Biotechnology (USA) and launched an FDA EUA approved SARS-COV-2 RT-PCR diagnostics test.

July 10, 2020—Diazyme Laboratories received FDA emergency use authorization for the Diazyme DZ-Lite SARS-CoV-2 IgG CLIA test.

March 25, 2020—Diazyme announced the availability of two serological tests for the novel coronavirus, 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.

Diazyme Laboratories has received FDA 510(k) clearance to market its new 25-hydoxy vitamin D assay, which measures total true 25-hydroxy vitamin D levels in serum and plasma samples. The assay automates the removal of nonspecific protein binding and cross-reactivity that may occur in competing assays, thereby ensuring results will be precise and accurate.