Diazyme DZ-Lite SARS-CoV-2 IgG/IgM CLIA serological tests were FDA notified pursuant to Section IV.D of FDAs policy on the public health emergency for COVID-19 (May 4, 2020 update compliant).
SAN DIEGO, Calif., May 22, 2020 (GLOBE NEWSWIRE) -- 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 decided not to commercialize the RAPID test and hence did not pursue it further.
Diazyme DZ-Lite SARS-CoV-2 IgG/IgM CLIA serological tests were FDA notified pursuant to Section IV.D of FDA’s policy on the public health emergency for COVID-19 (May 4, 2020 update compliant). Diazyme CLIA serological tests have been validated per Section V.C of the FDA policy on PHE for COVID-19. FDA has acknowledged the notification by posting the Diazyme serological method under FAQ section on serological tests.
Please see “Q. What commercial manufacturers are distributing serology test kits under the policy outlined in Section IV.D…..”
Diazyme has already submitted EUA for the laboratory run SARS-CoV-2 IgG/IgM CLIA kit, which are currently under FDA interactive review.
Diazyme Laboratories, Inc., a Life Science Affiliate of General Atomics, is located in Poway, California. Diazyme uses its proprietary enzyme and immunoassay technologies to develop diagnostic reagents run on automated chemistry analyzers and chemiluminescence instruments in user-friendly formats. Diazyme is a cGMP and ISO 13485 certified medical device manufacturer. Information regarding Diazyme's technology and products can be found on its website at www.diazyme.com
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