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FDA list of Serology Tests for SARS-CoV-2

FDA list of Serology Tests for SARS-CoV-2

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“serology tests” are a way of testing for the presence of antibodies that work against the SARS-2 virus.  

So it’s important, because other tests can yield false positives or false negatives.    Detecting the anti-bodies is more sure fire.    

OK. Done. Here is the FDA list of serology tests for SARS-CoV-2.

The FDA has not reviewed the validation of tests offered by these  developers, who will not be pursuing EUAs, and is including this list  here to provide transparency regarding the notifications submitted to  FDA.

BTNX, Inc. Rapid Response™ COVID-19 IgG/IgM Test Cassette
Coronacide™ COVID-19 IgM/IgG Rapid Test
Diazyme Laboratories, Inc.
Nirmidas Biotech, Inc.
Phamatech Inc. COVID19 IgG/IgM Rapid Test
Promedical
SD Biosensor Standard QCOVID-19 IgM/IgG
United Biomedical, Inc.
Zhuhai Encode Medical Engineering Co., Ltd
Zhuhai Livzon Diagnostics, Inc.

Source: FDA list of Serology Tests for SARS-CoV-2

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