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ELECSYS HBSAG LL QUANT LLROCHE - COFEPRIS Registration 156R2022 SSA

Access comprehensive regulatory information for ELECSYS HBSAG LL QUANT LLROCHE (ELECSYS HBSAG LL QUANT LLROCHE) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 156R2022 SSA and manufactured by PRODUCTOSROCHE, S.A. DE C.V.. The device was registered on March 04, 2022.

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
156R2022 SSA
ELECSYS HBSAG LL QUANT LLROCHE
COFEPRIS Analysis ID: 156R2022 SSA
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Product Use / Uso del Producto
Spanish

TESTINMUNOLÓGICOINVITROPARALADETERMINACIÓNCUANTITATIVA DEL ANTÍGENO DE SUPERFICIE DE LAHEPATITIS B (HBSAG) EN SUERO Y PLASMA HUMANOSCONFIRMADOS COMO POSITIVOS PARA HBSAG. ESTEINMUNOENSAYO DE ELECTROQUIMIOLUMINISCENCIA(ELECTROCHEMILUMINESCENCE IMMUNOASSAY) ”ECLIA”ESTÁPREVISTOPARASUUSOENINMUNOANALIZADORESROCHE.

English

INVITRO IMMUNOLOGICAL TEST FOR THE QUANTITATIVE DETERMINATION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA CONFIRMED AS POSITIVE FOR HBSAG. THIS ELECTROCHEMILUMINESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE IN IMMUNOANALYZERSROCHE.

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)
PRUEBA PARA LADETERMINACIÓN DELANTÍGENO DE SUPERFICIE DELA HEPATITIS B.
Trade Name (English)
TEST FOR THE DETERMINATION OF THE SURFACE ANTIGEN OF HEPATITIS B.
Registration Information
Analysis ID
156R2022 SSA
Registration Date
March 04, 2022
Manufacturer / Fabricante
Name (English)
PRODUCTOSROCHE, S.A. DE C.V.