Diazyme Laboratories, Inc. Receives FDA EUA for COVID-19 Antibody Test
SAN DIEGO, July 08, 2020 (GLOBE NEWSWIRE) -- Diazyme announces receiving FDA Emergency Use Authorization (EUA) letter for the Diazyme DZ-Lite SARS-CoV-2 IgG CLIA test.
- SAN DIEGO, July 08, 2020 (GLOBE NEWSWIRE) -- 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 public health emergency.
- The fully automated Diazyme DZ-Lite SARS-CoV-2 IgG test exceeds sensitivity and specificity requirements for laboratory run serology tests.