Trump Administration Bars FDA from Regulating Some Laboratory Tests, including for Coronavirus
The tests affected are those developed by and used at laboratories regulated under the Clinical Laboratory Improvement Amendments program.
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Search Results for: covid-19
FDA EUA Issued for LumiraDx Covid-19 Antigen Test
FDA has authorized the covid-19 antigen test for use in high and moderate complexity laboratories certified under CLIA and at the point of care.
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Veracyte, MaviDx Partner on Ultra-High-Volume Covid-19 Test
The ultra-high-volume covid-19 test approach may enable processing of over 40,000 patient samples per day using molecular barcodes for viral RNA.
Read MoreRayBiotech Seeks FDA EUA for 1-Step Covid-19 PCR Detection in Saliva
RayBiotech’s novel 1-Step Covid-19 PCR collection buffer allows for immediate use of the saliva and other sample types on authorized tests.
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LabMed Ships 65M Medical Masks, 38M VTM Kits to Fight Covid-19
LabMed’s VTMs help battle covid-19, as they come with the company’s nasal swab kits and they hold the completed swabs that will be sent to labs for testing.
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