Mexico COFEPRIS registration 2164R2019 SSA

PRECICONTROL HBSAG II QUANT II

EN: PRECICONTROL HBSAG II QUANT II
Mexico flagMexico·Clase II·III. DIAGNOSTIC AGENTS·PRODUCTOS ROCHE, S.A. DE C.V.·Registered November 20, 2019
Product Use / Uso del Producto
Spanish

PRECICONTROL HBSAG II QUANT II SE EMPLEA PARA EL CONTROL DE CALIDAD DEL INMUNOANÁLISIS ELECSYS HBSAG II QUANT II EN LOS INMUNOANALIZADORES ROCHE. AGENTE DE DIAGNÓSTICO PARA USO IN VITRO. PARA USO EXCLUSIVO EN LABORATORIOS CLÍNICOS O DE GABINETES.

English

PRECICONTROL HBSAG II QUANT II IS USED FOR QUALITY CONTROL OF THE ELECSYS HBSAG II QUANT II IMMUNOASSAY IN ROCHE IMMUNOANALYZERS. DIAGNOSTIC AGENT FOR IN VITRO USE. FOR USE IN CLINICAL OR CABINET LABORATORIES ONLY.

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)
REACTIVO CONTROL
Trade Name (English)
REACTIVE CONTROL
Registration information
Analysis ID
2164R2019 SSA
Registration Date
November 20, 2019
Manufacturer / Fabricante
Name (English)
PRODUCTOS ROCHE, S.A. DE C.V.
About this record

Access comprehensive regulatory information for PRECICONTROL HBSAG II QUANT II (PRECICONTROL HBSAG II QUANT II) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 2164R2019 SSA and manufactured by PRODUCTOS ROCHE, S.A. DE C.V.. The device was registered on November 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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