QUANTA FLASH® ENA 7 REAGENTS. - COFEPRIS Registration 2161R2019 SSA
Access comprehensive regulatory information for QUANTA FLASH® ENA 7 REAGENTS. (QUANTA FLASH® ENA 7 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 2161R2019 SSA and manufactured by I.L. DIAGNOSTICS, S.A. DE C.V.. The device was registered on November 20, 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 ENA7 ES UN INMUNOENSAYO POR QUIMIOLUMINISCENCIA PARA LA DETECCIÓN CUALITATIVA DE AUTOANTICUERPOS IGG CONTRA LOS ANTÍGENOS SM, RNP, RO60 (SS-A), RO52/TRIM21, SS-B (LA), SCL-70 (TOPOISOMERASA I) Y JO-1 EN SUERO HUMANO. AGENTE DE DIAGNÓSTIC
THE QUANTA FLASH ENA7 IS A CHEMILUMINESCENCE IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF IGG AUTOANTIBODIES AGAINST SM, RNP, RO60 (SS-A), RO52/TRIM21, SS-B (LA), SCL-70 (TOPOISOMERASE I) AND JO-1 ANTIGENS IN HUMAN SERUM. DIAGNOSTIC AGENT