SARS-CoV-2 IgM Antibody Test (colloidal gold immunochromatography) - ARCSA Registration 9a020e0841e36a0778c89b3f6e24250e
Access comprehensive regulatory information for SARS-CoV-2 IgM Antibody Test (colloidal gold immunochromatography) in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 9a020e0841e36a0778c89b3f6e24250e and manufactured by BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.. The device was registered on April 15, 2020.
This page provides complete registration details including product type (In Vitro Diagnostic), manufacturer information, authorized representative details, and regulatory compliance data from the official Ecuador ARCSA medical device database. Pure Global AI offers free access to Ecuador's complete medical device registry.
THE SARS-COV-2 IGM ANTIBODY TEST (COLLOIDAL GOLD IMMUNOCHROMATOGRAPHY) IS A LATERAL FLOW IMMUNOASSAY FOR THE SIMULTANEOUS DETECTION AND DIFFERENTIATION OF THE ANTI-COVID-19 IGG VIRUS AND THE ANTI-COVID-19 IGM VIRUS IN WHOLE BLOOD, SERUM OR HUMAN PLASMA. IT IS INTENDED TO BE USED BY PROFESSIONALS AS A SCREENING TEST AND AS AN AID IN THE DIAGNOSIS OF INFECTION BY COVID-19 VIRUS.