COVAXX RAPID TEST

UBI® SARS-CoV-2 ELISA

In response to the global epidemic of COVID-19, United Biomedical, Inc. (UBI) and its subsidiary COVAXX have developed UBI® SARS-CoV-2 ELISA, a serology test for the detection of IgG antibodies against the novel coronavirus SARS-CoV-2.

UBI, an American company located in Hauppauge, NY, has tests available for use as a screening method both to detect infections and to control the spreading wave of infections in accordance with section IV(D) of the March 16, 2020 FDA guidance, “Policy for Diagnostic Tests for Coronavirus Disease-2019 During the Public Health Emergency.” Additionally, pursuant to Section 564 of the FD&C Act, UBI has submitted for Emergency Use Authorisation (EUA) which is currently under review at the FDA. We have employed validation methodologies similar to those of our SARS test (SARS Antibody Test for Serosurveillance, Emerging Infectious Diseases September 2004: Vol 10, No. 9).

 

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