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SARS-COV-2 ANTIBODY CONTROL - COFEPRIS Registration 1827R2021 SSA

Access comprehensive regulatory information for SARS-COV-2 ANTIBODY CONTROL (SARS-COV-2 ANTIBODY CONTROL) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1827R2021 SSA and manufactured by PRODUCTOS ROCHE,S.A. DE C.V.. The device was registered on November 11, 2021.

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
1827R2021 SSA
SARS-COV-2 ANTIBODY CONTROL
COFEPRIS Analysis ID: 1827R2021 SSA
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Product Use / Uso del Producto
Spanish

ELCONTROLDEANTICUERPOSCONTRASARS-COV-2 ESTÁ PREVISTO PARA UTILIZARSECOMO UN MATERIAL DE CONTROL DECALIDAD EXTERNO PARA MONITOREAR ELRENDIMIENTO DE LA PRUEBA RÁPIDA DEANTICUERPOSCONTRASARSCOV-2. AGENTEDEDIAGNÓSTICOPARAUSOINVITRO. PARAUSOEXCLUSIVODELABORATORIOSCLÍNICOSO DE GABINETE.

English

THE CONTRASARS-COV-2 ANTIBODY CONTROL IS INTENDED TO BE USED AS AN EXTERNAL QUALITY CONTROL MATERIAL TO MONITOR THE PERFORMANCE OF THE RAPID ANTIBODY TESTCONTRASARSCOV-2. DIAGNOSTICAGENTFORUSEINVITRO. FOR EXCLUSIVE USE OF CLINICAL LABORATORIES OR CABINET.

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
1827R2021 SSA
Registration Date
November 11, 2021
Manufacturer / Fabricante
Name (English)
PRODUCTOS ROCHE,S.A. DE C.V.