The miniaturization of fluorescent PCR instruments is also a trend. Small PCR cyclers are portable and realize mobile detection.
The US Food and Drug Administration said on Friday evening that it has issued an Emergency Use Authorization for Lucira Health's Lucira COVID-19 & Flu test, the first over-the-counter, at-home diagnostic test that can differentiate and detect influenza A and B, as well as SARS-CoV-2.
On February 7 2023, RocGene's independently developed Archimed Mini 16 Medical Fluorescence Quantitative PCR Instrument obtained the Class III Medical Device Registration Certificate by the National Medical Products Administration.
French diagnostics maker BioMérieux said on Tuesday that it has received CE marking for its Vidas Kube automated immunoassay system.
KSL Pulse Scientific said Tuesday it will distribute Lucira Health's disposable molecular test for COVID-19 and influenzas A and B for over-the-counter use in Canada.
The US Food and Drug Administration on Tuesday granted Emergency Use Authorization for a molecular COVID-19/flu test from Lucira Health.
Lucira Health announced on Thursday that it has received authorization under an interim order from Health Canada to market the Lucira COVID-19 & Flu Test for emergency use.
Becton Dickinson has obtained the CE-IVD mark on a combined panel assay to detect SARS-CoV-2, influenza A and B, and respiratory syncytial virus. The assay runs on the firm's BD Max instrument and is now available in countries that recognize the CE mark, the firm said on Thursday.
Becton Dickinson announced on Thursday that it has obtained the CE-IVD mark for a combined influenza, SARS-CoV-2 assay. The multiplexed RT-PCR test runs on the firm's high-throughput BD Cor system.
DiaSorin's Luminex on Friday announced it has obtained CE marking for its Aries Flu A/B & RSV+SARS-CoV-2 Assay, a multiplex molecular panel that detects four common respiratory viruses and their underlying respiratory infections.
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