The US Food and Drug Administration this week granted separate Emergency Use Authorizations for a respiratory panel RT-PCR test from Laboratory Corporation of America and a COVID-19 RT-PCR test from Nexus Medical Labs.
Cepheid announced on Thursday that it has obtained the CE mark for a rapid molecular test to detect the SARS-CoV-2 virus. The new test will begin shipping this month.
LumiraDx on Thursday announced it has obtained CE marking for its five-minute SARS-CoV-2 Ag Ultra Test.
On May 18, the treatment report of the first Chinese produced SARS-CoV-2 oral drug was announced.
The Food and Drug Administration published a Class I recall report for two COVID-19 testing products that covers the removal of more than 51,000 unauthorized coronaviurs tests from the U.S. market.
On May 18, Yunkang Group was listed on Hong Kong Exchanges and Clearing Limited (HKEX), stock code: 2325.HK. At press time, it opened down over 10% with a total market capitalisation of approximately HK$4.3 billion.
On Monday, The US Food and Drug Administration issued an Emergency Use Authorization to Laboratory Corporation of America's Seasonal Respiratory Virus RT-PCR DTC test for use without a prescription by individuals with symptoms of COVID-19.
The US Food and Drug Administration earlier this month granted Emergency Use Authorization for Abbott's ID Now COVID-19 2.0 rapid point-of-care test.
Danaher subsidiary Cepheid announced on Thursday that its Xpert Xpress CoV-2 plus test has received Emergency Use Authorization from the US Food and Drug Administration.
Becton Dickinson has received 510(k) clearance from the US Food and Drug Administration for the MX molecular diagnostics module along with a triplex assay for chlamydia, gonorrhea, and trichomonas.
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