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KIT HEVYLITE® IGG KAPPA OPTILITE® - COFEPRIS Registration 256R2019 SSA

Access comprehensive regulatory information for KIT HEVYLITE® IGG KAPPA OPTILITE® (KIT HEVYLITE® IGG 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 256R2019 SSA and manufactured by INSUMOS PARA LA SALUD, S.A. DE C.V.. The device was registered on February 12, 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.

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COFEPRIS Official Data
Clase I
256R2019 SSA
KIT HEVYLITE® IGG KAPPA OPTILITE®
COFEPRIS Analysis ID: 256R2019 SSA
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Product Use / Uso del Producto
Spanish

EL KIT HEVYLITE® IGG KAPPA OPTILITE® ES UN ENSAYO IN VITRO CUANTITATIVO QUE PERMITE MEDIR LA IGG KAPPA (CADENA PESADA IGG Y CADENA LIGERA KAPPA DE INMUNOGLOBULINA INTACTA) EN SUERO O PLASMA OBTENIDA CON HEPARINA LITIO O EDTA, USANDO EL ANALIZADOR OPTILITE

English

THE HEVYLITE® IGG KAPPA OPTILITE KIT IS A QUANTITATIVE IN VITRO ASSAY THAT ALLOWS MEASURING IGG KAPPA (IGG HEAVY CHAIN AND INTACT IMMUNOGLOBULIN KAPPA LIGHT CHAIN) IN SERUM OR PLASMA OBTAINED WITH LITHIUM HEPARIN OR EDTA, USING THE OPTILITE® ANALYZER

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
REACTIVO PARA LA DETERMINACIÓN DE IGG KAPPA
Trade Name (English)
REAGENT FOR THE DETERMINATION OF IGG KAPPA
Registration Information
Analysis ID
256R2019 SSA
Registration Date
February 12, 2019
Manufacturer / Fabricante
Name (English)
INSUMOS PARA LA SALUD, S.A. DE C.V.