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ATELLICA ™ IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 - COFEPRIS Registration 588R2019 SSA

Access comprehensive regulatory information for ATELLICA ™ IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (ATELLICA ™ IM ANTI-HEPATITIS B SURFACE ANTIGEN 2) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 588R2019 SSA and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L DE C.V.. The device was registered on March 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.

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COFEPRIS Official Data
Clase II
588R2019 SSA
ATELLICA ™ IM ANTI-HEPATITIS B SURFACE ANTIGEN 2
COFEPRIS Analysis ID: 588R2019 SSA
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Product Use / Uso del Producto
Spanish

EL ENSAYO ATELLICA™ IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) ESTÁ PREVISTO PARA USO DIAGNÓSTICO IN VITRO EN LA DETERMINACIÓN CUALITATIVA Y CUANTITATIVA DEL TOTAL DE ANTICUERPOS CONTRA EL ANTÍGENO DE SUPERFICIE DE LA HEPATITIS B EN SUERO Y PLASMA (EDT

English

THE ATELLICA™ IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) ASSAY IS INTENDED FOR IN VITRO DIAGNOSTIC USE IN THE QUALITATIVE AND QUANTITATIVE DETERMINATION OF TOTAL ANTIBODIES AGAINST HEPATITIS B SURFACE ANTIGEN IN SERUM AND PLASMA (EDT)

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
ENSAYO PARA LA DETERMINACIÓN DE ANTICUERPOS CONTRA EL ANTÍGENO DE SUPERFICIE DEL VIRUS DE LA HEPATIT
Trade Name (English)
ASSAY FOR THE DETERMINATION OF ANTIBODIES AGAINST HEPATIT VIRUS SURFACE ANTIGEN
Registration Information
Analysis ID
588R2019 SSA
Registration Date
March 20, 2019
Manufacturer / Fabricante
Name (English)
SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L DE C.V.