The US Food and Drug Administration on Thursday granted separate Emergency Use Authorizations (EUAs) for PCR-based SARS-CoV-2 tests developed by South Korean diagnostic test makers BioCore, SolGent, and Seasun Biomaterials.
Grifols Diagnostic Solutions announced Thursday its Procelix Panther System featuring Automation Ready Technology (ART) received approval from the US Food and Drug Administration.
Moderator: Irene Aihie April 22, 2020 12:15 pm ET Coordinator: Welcome and thank you for standing by. At this time all parties are in a listen-only mode until the question and answer segment of todays conference at which time you may press
South Korean molecular diagnostics firm Seegene announced after the close of the market on Tuesday that the US Food and Drug Administration has granted Emergency Use Authorization for the firms Allplex 2019-nCoV Assay, a real-time RT-PCR te
The US Food and Drug Administration on Friday granted Emergency Use Authorization to the Rutgers Clinical Genomics Laboratory for a SARS-CoV-2 test originally developed by Thermo Fisher Scientific that is modified for use on additional spec
The US Food and Drug Administration on Friday granted Emergency Use Authorization to the Rutgers Clinical Genomics Laboratory for a SARS-CoV-2 test originally developed by Thermo Fisher Scientific that is modified for use on additional spec
The US Food and Drug Administration on Monday granted Emergency Use Authorization to two lab-developed real-time RT-PCR tests for SARS-CoV-2, the virus that causes coronavirus disease COVID-19. The authorized tests are performed at Knoxvill
FDA is upping its response to address the novel coronavirus outbreak. The policy is aimed at laboratories seeking to develop diagnostic tests for the coronavirus. The policy allows laboratories to develop and begin to use the diagnostics be
NEW YORK The US Food and Drug Administration on Friday granted Emergency Use Authorization to Luminex for the firms NxTag CoV Extended Panel to detect SARS-CoV-2 virus nucleic acids in nasopharyngeal swab specimens. High-complexity molecula
NEW YORK Avellino Labs on March 25 received Emergency Use Authorization for its coronavirus real-time PCR diagnostic test from the US Food and Drug Administration. The assay, called AvellinoCoV2 test, is designed for the detection of nuclei
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