RAPID RESPONSE™ COVID-19IGG/IGM RAPID TEST DEVICE - COFEPRIS Registration 1194R2021 SSA
Access comprehensive regulatory information for RAPID RESPONSE™ COVID-19IGG/IGM RAPID TEST DEVICE (RAPID RESPONSE™ COVID-19IGG/IGM RAPID TEST DEVICE) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1194R2021 SSA and manufactured by EMERGO,S.DER.L.DEC.V.. The device was registered on October 08, 2021.
This page provides complete registration details including product type (III. DIAGNOSTIC AGENTS), manufacturer information, and regulatory compliance data from the official Mexico COFEPRIS medical device database. Pure Global AI offers free access to Mexico's complete medical device registry with bilingual Spanish/English support, helping global MedTech companies navigate COFEPRIS regulations efficiently.
EL DISPOSITIVO DE PRUEBA RÁPIDA RAPIDRESPONSE ™ COVID 19 IGG / IGM ES UNINMUNOENSAYO IN VITRO PARA LADETECCIÓNDIRECTAYCUALITATIVADEIGMANTI-SARSCOV2YANTI-SARSCOV2IGGENSANGRE COMPLETA, SUERO O PLASMAHUMANOS. LOS RESULTADOS OBTENIDOSCON ESTA PRUEBA SOLO DEBENINTERPRETARSE JUNTO CON OTROSPROCEDIMIENTOS DE DIAGNÓSTICO YHALLAZGOS CLÍNICOS. EL DISPOSITIVO DEPRUEBARÁPIDARAPIDRESPONSE™COVID19 IGG / IGM NO DEBE USARSE PARADIAGNOSTICAR O EXCLUIR UNA INFECCIÓNAGUDA POR SARS
THE COVID 19 IGG/IGM RAPIDRESPONSE ™ RAPID TEST DEVICE IS AN IN VITRO IMMUNOASSAY FOR DIRECT AND QUALITATIVE DETECTION OF HUMAN WHOLE BLOOD, SERUM OR PLASMA. THE RESULTS OBTAINED WITH THIS TEST SHOULD ONLY BE INTERPRETED IN CONJUNCTION WITH OTHER DIAGNOSTIC PROCEDURES AND CLINICAL FINDINGS. THE RAPIDRESPONSE™COVID19 IGG/IGM RAPID TEST DEVICE SHOULD NOT BE USED TO DIAGNOSE OR EXCLUDE ACUTE SARS INFECTION