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The Diagnostic Kit for 25 SARS-CoV-2 IgM/IgG Antibody (Colloidal Gold) tests from KHB adopts the solid phase colloidal gold immunochromatographic technology for the qualitative determination of IgM/IgG antibodies against SARS-CoV-2 in human serum, plasma, and whole blood. Complementary to nucleic acid detection methodologies can be better achieved, providing a more comprehensive reference for clinical diagnosis.
The products have been determined to be up to the compliance requirements in medical device related EU directives and have been registered with competent EU authorities and eligible for accessing EU market.
The certificated products are Diagnostic Kit for SARS-CoV-2 Nucleic Acid (Real-time PCR), Diagnostic Kit for SARS-CoV-2 IgM/IgG Antibody (Colloidal Gold), Diagnostic Kit for SARS-CoV-2 IgM Antibody (ELISA) and Diagnostic Kit for SARS-CoV-2 IgG Antibody (ELISA). These four SARS-COV-2 diagnostic kits cover molecular diagnostics and immunoassay and include products for testing whole blood samples in circumstances that demand rapid diagnostics.
The development and certification of the SARS-COV-2 detection related products embody the company's product-centered and market-oriented core strategy to identify new growth poles for opening up new markets by prompt release of new IVD products in the fields of molecular diagnostics, immunoassay, and biochemistry tests.
The FSCs granted to KHB will be good for the company's development of international markets and the prevention and control of SARS-COV-2 epidemic worldwide.