The California-based firm said that its VeriClear EbV MARV Rapid Antigen Test will be used for the detection and differentiation of Ebola and Marburg virus infections.
The US Food and Drug Administration granted 510(k) marketing clearances for various tests to aid the diagnosis and treatment of infectious diseases, among other products.
As the shutdown drags out, there could be delays in regulatory processes and payments for medical services as well as the ...
Researchers hope to soon commercialize a simple, inexpensive, and accessible screening test that uses taste as a detection ...
Regulatory burdens have raised the capital requirements for early-stage companies, causing many to do what would have been ...
Having expanded access to quantitative hemoglobin variant testing in 40 countries, Hemex is now also setting its sights on the US and Europe.
The University of Washington spinout's test is used to detect and analyze protein biomarkers in a low-cost test, with results in 15 minutes.
The firms intend to comarket genomic solutions combining clinical decision support and genomic workflow integration with microarray testing.
Sebia sells electrophoresis instruments and protein-based IVDs for use in multiple myeloma as well as metabolic, autoimmune, and inflammatory conditions.