RE: April 2021, Vatic Health14 Oct 2021 20:58
rxdav. No, is the short answer.
Can you have a look at this link and go to page 3.
Diseases 2021. Regulatory Framework and Introduction of Salivary Diagnostics for COVID-19
"in the United States, the Centers for Disease Control and Prevention (CDC) works closely with the Federal Drug Administration (FDA) who are responsible for the issuance of an interim regulatory approval, known as the Emergency Use Authorization (EUA),which companies working in the COVID-19 testing area are required to obtain before commercializing their speci?c tests. The FDA is also responsible for the issuance of guidance documents to provide policy and a framework for laboratories and commercial manufacturers to accelerate the availability of alternate novel coronavirus (COVID-19)tests [9,10]. Following the CDC and FDA’s policy guidelines, the Rutgers Clinical Genomics Laboratory and In?nite Biologics, using the Thermo Fisher TaqPath™SARS-CoV-2 assay for high throughput testing, obtained EUA approval in April 2020 enabling them to begin commercializing their salivary test for SARS-CoV-2 [11]. Table 1shows a timeline of the salivary testing kit.
Notice in Table 1, headed "Timeline of the saliva collection devices for the SARS-CoV-2 sampling during the pandemic."
Vatic is listed at no. 20 as being launched in UK October 20. Does this mean Vatic have been granted by the US FDA the Emergency Use Authorization (EUA), which companies working in the COVID-19 testing area are required to obtain before commercializing their speci?c tests. ! Apologies if this is old news , but i still reading up here.
https://www.researchgate.net/publication/351714292_Saliva_Exhibits_High_Sensitivity_and_Specificity_for_the_Detection_of_SARS-COV-2
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