Effective August 31, 2020, Blackhawk signed a definitive agreement with Medigen Biotechnology Corporation and TBG Biotechnology Corp. to distribute certain diagnostic products, including an ExProbe SARS-CoV-2 Testing Kit and a SARS-CoV-2 IgG/IgM Rapid Test Kit used in the detection of antibodies associated with COVID-19. Both testing kits are EUA approved by the FDA.
Intended Use: Qualitative detection of nucleic acid from SARS-CoV-2 in NP/O swabs, NP and nasal aspirate specimens, and bronchoalveolar lavage (BALs).
Authorized Labs: CLIA H Labs
Product Format: 96 Tests/Kit
Kit Contents: PCR Mix, Enzyme Mix, Pos. Control, Neg. Control, and Instructions for Use
Storage/Stablility: -20±5°C for 6 months
*Kits are made in Taiwan, and contents not including PCR plate, sealing film, qPCR system, pipettes, and centrifuge.
Intended Use: Qualitative detection and differentiation of IgG and IgM antibodies to SARS-C0V-2 and human serum and plasma (Acid Citrate Dextrose (ACD))
Authorized Labs: CLIA H Labs and M Labs
Product Format: 25 Tests/Kit
Kit Contents: Disposable test card, disposable plastic capillary tubes, lancet, sample diluent, instructions for Use.
Storage/Stablility: CE (2 to 30°C for 12 months). FDA-EUA (2 to 8C for 9 months)
*Kits are made in Taiwan
About Medigen Biotechnology Corp.
Established in late 1999, Medigen Biotechnology Corp. (MBC) is a publicly traded company listed on the Taiwanese Stock Exchange. The company upholds the vision of “Innovations for a better life” focusing on the development of new therapies for liver diseases and cancers.
MBC has now developed into a comprehensive biopharmaceutical corporation with business fields covering new drug development, innovative drug discovery, molecular diagnostics, vaccine, and generic drugs. Combining Taiwan’s biomedical research capabilities, international clinical development experiences and competitiveness in commercialization of state-of-the-art technologies, Medigen has built up a portfolio of patent protected projects which will be transformed into products approved by the regulatory bodies of various countries.
For more information on Medigen, please visit their website here: http://www.medigen.com.tw/en/home/
About TBG Biotechnology Corp.
TBG Biotechnology Corp. (TBG) is a global molecular diagnostics company dedicated to the development, manufacture and marketing of molecular diagnostics kits, instruments and services. With its research and development based in the US, Taiwan and China, TBG manufactures its products in its ISO13485 certified facility in Xiamen, China serving the clinical labs of both hospitals and independent reference labs, blood centers and bone marrow registry labs around the world.
For more information on TBG, please visit their website here: http://www.tbgbio.com/en
Blackhawk is the sole entity with whom Medigen has entered into a distribution agreement for the non-exclusive distribution of the following products in North America: TBG SARS-CoV-2 IgG/IgM Rapid Test Kit & TBG ExProbe SARS-CoV-2 Testing Kit