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Latest From Quidel Corporation

FDA Eager To Authorize More Rapid Antigen COVID-19 Tests

The US FDA’s diagnostics chief says the agency isn’t seeing many submissions for rapid antigen tests, but is eager to authorize them. 

Regulation Approvals

BD Gets COVID-19 ‘Game-Changer’ Antigen Test Authorized By FDA

As the US sees another massive spike in COVID-19 cases, public health officials are concerned that not enough testing is available. But the FDA’s EUA for BD’s antigen test could change the game, rapidly testing more of the population for the coronavirus.

Commercial Regulation

Test, Medical Supply Manufacturers Working With Federal Agencies To Deter Second COVID-19 Wave

To better control a possible secondary wave of coronavirus cases over the summer as some state governors reopen their economies for businesses, US federal agencies are working with test and medical supply manufacturers to expand capacity, officials told Congress.

Policy Coronavirus COVID-19

First Rapid COVID-19 Antigen Test Gets Green Light

In a potential game-changer in the ongoing fight to expand COVID-19 testing, the FDA has authorized a new kind of test that can be used by certain health care providers on-site to diagnose patients with the SARS-CoV-2 virus within minutes instead of days.

Coronavirus COVID-19 Regulation
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Company Information

  • Industry
  • In Vitro Diagnostics
    • Chemistry, Immunoassay
    • Cytology
    • Molecular Diagnostics & Genetic Testing
    • Therapeutic Drug Monitoring
  • Other Names / Subsidiaries
    • AnDiaTec
    • BioHelix Corporation
    • Diagnostic Hybrids, Inc.