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  • FDA Coronavirus COVID-19 Update - - - FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19 | site |


    Test is authorized for individuals two years of age or older, including those not showing symptoms


    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 15, 2020)

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older. “Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over- the-c
    ...
    See more | Go to post

  • HHS Provides 25 Million Dollars to Siemens Healthineers to Develop and Produce COVID-19 Antigen Diagnostic Tests

    U.S. Department of Health and Human Services Provides $25 Million to Siemens Healthineers to Develop and Produce COVID-19 Antigen Diagnostic Tests | site |


    Dual Contracts Will Yield Two New Antigen Tests and Update Massachusetts Facility to Produce up to 50 Million Tests Per Month


    (Information contained in U.S. Department of Health and Human Services press release: November 19, 2020) Today, the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Defense (DoD) awarded Siemens Healthineers a $12 million contract to support domestic production of two diagnostic tests for SARS-CoV-2, the virus that causes COVID-19. The funding is in addition to a $13 million HHS contract awarded Nov. 2 to enable the company to develop the tests. Combined, the two contracts represent another $25 million investment by the federal government to expand the types of tests for COVID-19 and to ensure that sufficient numbers of tests are available ...
    See more | Go to post

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  • Staff Reporter 1
    FDA Coronavirus COVID-19 Update - - - FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19
    by Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19 | site |


    Test is authorized for individuals two years of age or older, including those not showing symptoms


    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 15, 2020)

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older. “Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over- the-c
    ...
    12-16-2020, 06:34 AM
  • Staff Reporter 1
    HHS Provides 25 Million Dollars to Siemens Healthineers to Develop and Produce COVID-19 Antigen Diagnostic Tests
    by Staff Reporter 1
    U.S. Department of Health and Human Services Provides $25 Million to Siemens Healthineers to Develop and Produce COVID-19 Antigen Diagnostic Tests | site |


    Dual Contracts Will Yield Two New Antigen Tests and Update Massachusetts Facility to Produce up to 50 Million Tests Per Month


    (Information contained in U.S. Department of Health and Human Services press release: November 19, 2020) Today, the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Defense (DoD) awarded Siemens Healthineers a $12 million contract to support domestic production of two diagnostic tests for SARS-CoV-2, the virus that causes COVID-19. The funding is in addition to a $13 million HHS contract awarded Nov. 2 to enable the company to develop the tests. Combined, the two contracts represent another $25 million investment by the federal government to expand the types of tests for COVID-19 and to ensure that sufficient numbers of tests are available ...
    11-21-2020, 09:09 AM

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