Diazyme Laboratories, Inc. Receives FDA EUA for COVID-19 Antibody Test
8th Jul 2020
SAN DIEGO, CA (July 8, 2020)
Diazyme announces receiving FDA Emergency Use Authorization (EUA) letter for the Diazyme DZ-Lite SARS-CoV-2 IgG CLIA test. The Diazyme IgG test is run on the fully automated DZ-Lite 3000 Plus chemiluminescence analyzer.
"Diazyme has been at the forefront of the development effort to bring timely, high quality COVID-19 serology (antibody) tests during the publi
…
Diazyme Announces Continued Availability of COVID-19 Laboratory Run Antibody Tests
22nd May 2020
SAN DIEGO, CA – May 22, 2020 – Diazyme is making a statement to clear any confusion due to FDA’s May 21 press release regarding delisted tests from the FDA FAQ website.
Diazyme had two types of tests under Section IV.D notification of FDA’s policy on the public health emergency for COVID-19. The Diazyme high-throughput laboratory run CLIA antibody test is NOT subject of delisting.
Diazyme decid
…
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
…