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ATELLICA IM ANTÍGENO DEL CORE HEPATITIS B (AHBCM) - COFEPRIS Registration 609R2019 SSA

Access comprehensive regulatory information for ATELLICA IM ANTÍGENO DEL CORE HEPATITIS B (AHBCM) (ATELLICA IM CORE HEPATITIS B ANTIGEN (AHBCM)) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 609R2019 SSA and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L DE C.V.. The device was registered on March 26, 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
609R2019 SSA
ATELLICA IM ANTÍGENO DEL CORE HEPATITIS B (AHBCM)
COFEPRIS Analysis ID: 609R2019 SSA
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Product Use / Uso del Producto
Spanish

EL ENSAYO ATELLICA™ IM HEPATITIS B CORE ANTIGEN (AHBCM) ESTÁ PREVISTO PARA USO DIAGNÓSTICO IN VITRO EN LA DETERMINACIÓN CUALITATIVA DE RESPUESTA AL IGM PARA EL ANTÍGENO DEL CORE DEL VIRUS DE LA HEPATITIS B (HBC IGM) EN SUERO Y PLASMA HUMANOS (EDTA, HEPARI

English

THE ATELLICA™ IM HEPATITIS B CORE ANTIGEN (AHBCM) ASSAY IS INTENDED FOR IN VITRO DIAGNOSTIC USE IN THE QUALITATIVE DETERMINATION OF IGM RESPONSE FOR HEPATITIS B VIRUS CORE ANTIGEN (HBC IGM) IN HUMAN SERUM AND PLASMA (EDTA, HEPARI

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 IGM CONTRA EL ANTÍGENO DEL CORE DE LA HEPATITIS B.
Trade Name (English)
ASSAY FOR THE DETERMINATION OF IGM ANTIBODIES AGAINST HEPATITIS B CORE ANTIGEN.
Registration Information
Analysis ID
609R2019 SSA
Registration Date
March 26, 2019
Manufacturer / Fabricante
Name (English)
SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L DE C.V.