This product has aleady completed the European In Vitro Diagnostic Medical Devices Dirctive (IVDD) compliance statement and registration in the European Union, and has been Qualified for EU market access.
COVID-19 (SARS-COV-2) IGM/IGG Antibody Fast Detection Kit ( Colloidal Gold) adopts colloidal gold immunochromatography assay (GICA) . The test card contains 1.) colloidal gold labeled antigen and quality control antibody complex, 2.) Nitrocellulose membranes immobilized with two test lines (M line and G line) and one quality control line (C line).