QUANTA FLASH® ENA7CALIBRATORS - COFEPRIS Registration 181R2020 SSA
Access comprehensive regulatory information for QUANTA FLASH® ENA7CALIBRATORS (QUANTA FLASH® ENA7CALIBRATORS) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 181R2020 SSA and manufactured by I.L. DIAGNOSTICS, S.A. DE C.V.. The device was registered on February 20, 2020.
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.
LOSCALIBRADORESDELQUANTAFLASHENA7ESTÁN DESTINADOS A UTILIZARSE CON LOSREACTIVOSDELQUANTAFLASHENA7PARALADETERMINACIÓN DE AUTOANTICUERPOS IGGCONTRALOSANTÍGENOSSM,RNP,RO60(SS-A),RO52/TRIM21, SS-B (LA), SCL-70(TOPOISOMERASAI)YJO-1ENSUEROHUMANO.CADACALIBRADORESTABLECEUNPUNTODEREFERENCIAPARALACURVADETRABAJOQUESE EMPLEA PARA CALCULAR LOS VALORESUNITARIOS.
QUANTAFLASHENA7 CALIBRATORS ARE INTENDED FOR USE WITH QUANTAFLASHENA7 REAGENTS FOR THE DETERMINATION OF IGG AUTOANTIBODIES AGAINST SSM, RNP, RO60(SS-A),RO52/TRIM21, SS-B (LA), SCL-70(TOPOISOMERASAI)AND 1ENSUEROHUMAN. EACH CALIBRATOR ESTABLISHES A REFERENCE POINT FOR THE WORK CURVE WHICH IS USED TO CALCULATE UNIT VALUES.