emergency use authorization
FDA Grants EUA for Scope Molecular Laboratory SARS-CoV-2 Test for Serial Testing
The laboratory-developed test uses RT-PCR to detect SARS-CoV-2 RNA in anterior nasal swab specimens either self-collected or collected by a healthcare professional.
DiaCarta Nabs FDA Emergency Use Authorization for Monkeypox Test
The laboratory-use QuantiVirus MPXV Test Kit targets two regions of the MPXV genome to detect the virus even if mutations occur in one target region.
Top Five Articles on 360Dx Last Week: Visby Gets FDA EUA; DoD Contract for COVID Tests; and More
Last week, readers were most interested in FDA awarding Emergency Use Authorization for Visby's point-of-care test for influenza A/B and COVID.
Aided by COVID-19 Funding, Firms Continued Developing Handheld Diagnostic Instruments in 2022
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The lightweight, portable instruments coming onto the market employ promise to deliver test results closer to patients, potentially hastening treatments.
Becton Dickinson Monkeypox PCR Assay Granted FDA Emergency Use Authorization
The PCR test is designed to qualitatively detect monkeypox virus DNA in human lesion swab samples from patients suspected of monkeypox infection.