KIT HEVYLITE® IGM KAPPA OPTILITE® - COFEPRIS Registration 2616R2018 SSA
Access comprehensive regulatory information for KIT HEVYLITE® IGM KAPPA OPTILITE® (KIT HEVYLITE® IGM KAPPA OPTILITE®) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 2616R2018 SSA and manufactured by INSUMOS PARA LA SALUD, S.A. DE C.V.. The device was registered on November 13, 2018.
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 KIT HEVYLITE® IGM KAPPA OPTILITE® ES UN ENSAYO IN VITRO CUANTITATIVO QUE PERMITE MEDIR LA IGM KAPPA (CADENA PESADA IGM Y CADENA LIGERA KAPPA DE INMUNOGLOBULINA INTACTA) EN SUERO O PLASMA OBTENIDA CON HEPARINA LITIO O EDTA, USANDO EL ANALIZADOR OPTILITE
THE HEVYLITE® IGM KAPPA OPTILITE KIT IS A QUANTITATIVE IN VITRO ASSAY THAT ALLOWS THE MEASUREMENT OF KAPPA IGM (IGM HEAVY CHAIN AND INTACT IMMUNOGLOBULIN KAPPA LIGHT CHAIN) IN SERUM OR PLASMA OBTAINED WITH LITHIUM HEPARIN OR EDTA, USING THE OPTILITE® ANALYZER