Mexico COFEPRIS registration 606R2019 SSA

ATELLICA IM HEPATITIS B E ANTIGEN

EN: ATELLICA IN HEPATITIS B E ANTIGEN
Mexico flagMexico·Clase II·III. DIAGNOSTIC AGENTS·SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L. DE C.V.·Registered March 26, 2019
Product Use / Uso del Producto
Spanish

EL ENSAYO ATELLICA™ IM HEPATITIS B E ANTIGEN (HBEAG) ESTÁ PREVISTO PARA USO DIAGNÓSTICO IN VITRO EN LA DETERMINACIÓN CUALITATIVA DEL ANTÍGENO E DEL VIRUS DE LA HEPATITIS B (HBEAG) EN SUERO Y PLASMA HUMANOS (EDTA, HEPARINA DE LITIO Y HEPARINA DE SODIO). E

English

THE ATELLICA™ IM HEPATITIS B AND ANTIGEN ASSAY (HBEAG) IS INTENDED FOR IN VITRO DIAGNOSTIC USE IN THE QUALITATIVE DETERMINATION OF HEPATITIS B VIRUS E ANTIGEN (HBEAG) IN HUMAN SERUM AND PLASMA (EDTA, LITHIUM HEPARIN AND SODIUM HEPARIN). And

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 DEL ANTÍGENO E DEL VIRUS DE LA HEPATITIS B
Trade Name (English)
HEPATITIS B VIRUS E ANTIGEN ASSAY
Registration information
Analysis ID
606R2019 SSA
Registration Date
March 26, 2019
Manufacturer / Fabricante
Name (English)
SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L. DE C.V.
About this record

Access comprehensive regulatory information for ATELLICA IM HEPATITIS B E ANTIGEN (ATELLICA IN HEPATITIS B E ANTIGEN) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 606R2019 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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