The US Food and Drug Administration this week granted Emergency Use Authorization for the Cleveland Clinic's SelfCheck Cobas SARS-CoV-2 + Flu Assay.
The US Food and Drug Administration on Thursday announced it has granted Emergency Use Authorization to InspectIR Systems' InspectIR COVID-19 Breathalyzer test, making it the first breath-based test for detecting SARS-CoV-2 to receive such designation.
Shanghai Fosun Pharmaceutical on Thursday announced that China's National Medical Products Administration (NMPA) has granted approval for Fosun Diagnostic's Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Colloidal Gold) for COVID-19 screening.
On April 13, the SARS-CoV-2 Rapid Antigen Test (immunochromatography Assay) developed by Sansure Biotech Inc. has obtained CE certification! This means that the test can be sold in EU countries and countries that recognize EU CE certification.
On April 13, National Medical Products Administrations (NMPA) reviewed and approved Zhuhai Livzon Diagnostics Inc. and Shanghai BioGerm Medical Technology Co., Ltd's COVID-19 Antigen Test.
The US Food and Drug Administration last week granted separate Emergency Use Authorizations for a PCR-based SARS-CoV-2 test developed by the University of California, San Diego and an at-home nasal specimen collection kit from the Washington D.C. Department of Health.
CLS.CN reported on April 12 that Andon Health announced that the net profit in the first quarter is expected to be CNY 14 billion to CNY 16 billion, a year-on-year increase of 36707.43% to 41965.63%.
The US Food and Drug Administration this week granted separate Emergency Use Authorizations for over-the-counter SARS-CoV-2 antigen self-tests developed by Osang Healthcare.
The scientists, led by Joseph Vinetz, MD, an infectious diseases specialist, were interested to find out if an oral medication used to treat pancreatitis could reduce the viral load (the amount of virus in your body) of SARS-CoV-2 and improve symptoms in people newly diagnosed with COVID-19.
The Biden-Harris Administration announced on April 4 that more than 59 million Americans with Medicare Part B, including those enrolled in a Medicare Advantage plan, now have access to Food and Drug Administration (FDA) approved, authorized, or cleared OTC COVID-19 tests at no cost.
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