Mexico COFEPRIS registration 2567R2018 SSA

MUREX HBSAG VERSION 3.

EN: MUREX HBSAG VERSION 3.
Mexico flagMexico·Clase II·III. DIAGNOSTIC AGENTS·DIASORIN MÉXICO, S.A. DE C.V.·Registered November 07, 2018
Product Use / Uso del Producto
Spanish

MUREX HBSAG VERSION 3 ES UN ENZIMOINMUNOANÁLISIS RÁPIDO Y SENSIBLE PARA LA DETECCIÓN DEL ANTÍGENO DE SUPERFICIE DEL VIRUS DE LA HEPATITIS B EN SUERO O PLASMA HUMANO. ESTE ENSAYO ESTÁ INDICADO PARA CRIBAR MUESTRAS INDIVIDUALES DE DONANTES HUMANOS A FIN

English

MUREX HBSAG VERSION 3 IS A RAPID AND SENSITIVE ENZYME IMMUNOASSAY FOR THE DETECTION OF HEPATITIS B VIRUS SURFACE ANTIGEN IN HUMAN SERUM OR PLASMA. THIS ASSAY IS INDICATED FOR SCREENING INDIVIDUAL SAMPLES FROM HUMAN DONORS IN ORDER TO

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 INMUNOLÓGICO PARA LA DETECCIÓN DEL ANTÍGENO DE SUPERFICIE DE HEPATITIS B EN SUERO HUMANO O PL
Trade Name (English)
IMMUNOLOGICAL ASSAY FOR THE DETECTION OF HEPATITIS B SURFACE ANTIGEN IN HUMAN SERUM OR PL
Registration information
Analysis ID
2567R2018 SSA
Registration Date
November 07, 2018
Manufacturer / Fabricante
Name (English)
DIASORIN MÉXICO, S.A. DE C.V.
About this record

Access comprehensive regulatory information for MUREX HBSAG VERSION 3. (MUREX HBSAG VERSION 3.) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 2567R2018 SSA and manufactured by DIASORIN MÉXICO, S.A. DE C.V.. The device was registered on November 07, 2018.

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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