QUANTA FLASH® M2 (MIT3) REAGENTS - COFEPRIS Registration 1751R2019 SSA
Access comprehensive regulatory information for QUANTA FLASH® M2 (MIT3) REAGENTS (QUANTA FLASH® M2 (MIT3) REAGENTS) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1751R2019 SSA and manufactured by I.L. DIAGNOSTICS, S.A. DE C.V.. The device was registered on August 27, 2019.
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 QUANTA FLASH® M2 (MIT3) ES UN INMUNOENSAYO POR QUIMIOLUMINISCENCIA PARA LA DETERMINACIÓN SEMICUANTITATIVA DE ANTICUERPOS IGG ANTIMITOCONDRIALES EN SUERO HUMANO. LA PRESENCIA DE ANTICUERPOS ANTIMITOCONDRIALES, JUNTO CON LOS DATOS CLÍNICOS Y OTRAS PRUEBA
THE QUANTA FLASH® M2 (MIT3) IS A CHEMILUMINESCENCE IMMUNOASSAY FOR THE SEMIQUANTITATIVE DETERMINATION OF ANTIMITOCHONDRIAL IGG ANTIBODIES IN HUMAN SERUM. THE PRESENCE OF ANTIMITOCHONDRIAL ANTIBODIES, ALONG WITH CLINICAL DATA AND OTHER EVIDENCE