Company Product Description Indication Status
Becton, Dickinson and Co. (BD), of Franklin Lakes, N.J., and Biogx Inc., of Birmingham, Ala. Biogx SARS-CoV-2 Reagents for BD Max system Assay is based on the same viral RNA targeting sequences and real-time PCR detection method as the CDC-developed test; provides results within 3 hours Enables hospitals to screen for COVID-19 on site; detects RNA from the SARS-CoV-2 virus Received emergency use authorization from the U.S. FDA
Beroni Group Ltd., of Sydney SARS-CoV-2 IgG/IgM Antibody Detection Kit Single-use immunochromatographic test that provides results within 10 minutes For the qualitative detection of IgG and IgM protein from the SARS-CoV-2 virus in capillary fingerstick whole blood, plasma, and serum samples Received the CE mark
Clinical Laserthermia Systems AB, of Lund, Sweden Thermoguide Surgical guidance software for Tranberg system Provides real-time information on temperature development as well as the achieved level of tissue destruction Received EC certification
Clinical Laserthermia Systems AB, of Lund, Sweden Tranberg Thermal Therapy System Laser-based system For image-guided laser ablation of tumors Received updated EC certification to work with new software
Leica Biosystems Nussloch GmbH, of Nussloch, Germany Aperio Imagescope DX Viewer Software to view images acquired on the Aperio AT2 DX Scanner For in vitro diagnostic use to aid a pathologist Received notification from the U.S. FDA that its software can be used for remote diagnosis under emergency use due to the COVID-19 pandemic

Notes

For more information about individual companies and/or products, see Cortellis.

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