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IMMUNOLOGY KIT ANTIBODY TO HEPATITIS B E ANTIGEN ANTI-HBE (CLIA) - COFEPRIS Registration 1106R2019 SSA

Access comprehensive regulatory information for IMMUNOLOGY KIT ANTIBODY TO HEPATITIS B E ANTIGEN ANTI-HBE (CLIA) (IMMUNOLOGY KIT ANTIBODY TO HEPATITIS B E ANTIGEN ANTI-HBE (CLIA)) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1106R2019 SSA and manufactured by MINDRAY MEDICAL Mร‰XICO, S. DE R.L. DE C.V.. The device was registered on May 21, 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 II
1106R2019 SSA
IMMUNOLOGY KIT ANTIBODY TO HEPATITIS B E ANTIGEN ANTI-HBE (CLIA)
COFEPRIS Analysis ID: 1106R2019 SSA
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Product Use / Uso del Producto
Spanish

EL ENSAYO DE ANTI-HBE QUE SE REALIZA EN LA SERIE CL ES UN INMUNOENSAYO QUIMIOLUMINISCENTE (CLIA) PARA LA DETERMINACIร“N CUALITATIVA DEL ANTICUERPO CONTRA EL ANTรGENO E DE LA HEPATITIS B (ANTI-HBE) EN PLASMA O SUERO DE ORIGEN HUMANO.

English

THE ANTI-HBE ASSAY PERFORMED IN THE CL SERIES IS A CHEMILUMINESCENT IMMUNOASSAY (CLIA) FOR THE QUALITATIVE DETERMINATION OF ANTIBODY AGAINST HEPATITIS B E ANTIGEN (ANTI-HBE) IN PLASMA OR SERUM OF HUMAN ORIGIN.

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
III. AGENTES DE DIAGNร“STICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
REACTIVO PARA LA DETERMINACIร“N DEL ANTICUERPO CONTRA EL ANTรGENO E DE LA HEPATITIS B
Trade Name (English)
REAGENT FOR THE DETERMINATION OF ANTIBODY AGAINST HEPATITIS B E ANTIGEN
Registration Information
Analysis ID
1106R2019 SSA
Registration Date
May 21, 2019
Manufacturer / Fabricante
Name (English)
MINDRAY MEDICAL MEXICO, S. DE R.L. DE C.V.