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Cepheid Gets CE Mark for Updated Rapid COVID MDx Test
2022-05-20
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 Obtains CE Mark for Five-Minute SARS-CoV-2 Antigen Test
2022-05-20
LumiraDx on Thursday announced it has obtained CE marking for its five-minute SARS-CoV-2 Ag Ultra Test.
The first Chinese oral drug report for SARS-CoV-2 announced
2022-05-19
On May 18, the treatment report of the first Chinese produced SARS-CoV-2 oral drug was announced.
FDA posts Class I recall report for 51,000 rapid antigen COVID-19 tests
2022-05-19
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.
Hong Kong Dx Firm Prenetics Shares Down 9 Percent on First Day on Nasdaq
2022-05-19
Genomics and diagnostics company Prenetics ended its first day as publicly traded company on the Nasdaq on Wednesday with its stock down 9 percent.
Yunkang Group Successfully Listed On the HKEX
2022-05-18
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.
FDA Issues First EUA for Non-Prescription COVID-19/Flu/RSV Test
2022-05-18
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.
Achiko Obtains CE Mark, IVDR Registration for Aptamer-Based COVID-19 Antigen Test
2022-05-18
Achiko announced Tuesday that it has obtained the CE mark for its COVID-19 AptameX test and system, enabling its use in the European Union and other regions that accept the designation.
Fosun Pharma plans to increase capital of Fosun Kite by USD 50 million
2022-05-17
On May 14, Fosun Pharma announced that its holding subsidiary Fosun Pharma Industry signed a contract with Kite Pharma. Proportional capital increase, and subscription of the new registered capital equivalent to Fosun Kite.
Qiagen Gets CE Mark for High-Capacity Syndromic Testing Platform
2022-05-17
Qiagen said on Monday that a higher-capacity version of its QiaStat-Dx automated syndromic testing system has received CE marking.
Abbott Gets FDA Emergency Use Authorization for Point-of-Care COVID-19 Test
2022-05-17
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.
Abbott Gets FDA Emergency Use Authorization for Point-of-Care COVID-19 Test
2022-05-17
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.
The 14th Five-Year Plan for Bioeconomic Development, IVD industry face the epic benefits!
2022-05-16
On May 10, the National Development and Reform Commission issued the "14th Five-Year Plan for Bio-economic Development" (hereinafter referred to as the "Plan"), which is also the first top-level design in China's bio-economic field.
GenDx Gets IVDR Certificate for HLA Typing Products
2022-05-16
Dutch molecular diagnostics firm Genome Diagnostics said on Friday that it has received a European Union Quality Management System Certificate under the new In Vitro Diagnostic Medical Devices Regulation (IVDR) for its portfolio of human leukocyte antigen (HLA) products.
BioMérieux Gets CE Mark for Vidas Chikungunya Assays
2022-05-16
BioMérieux announced on Friday that it has obtained the CE mark for two immunoassays to detect Chikungunya virus infection.
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