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ALINITY C RF. - COFEPRIS Registration 2282R2019 SSA

Access comprehensive regulatory information for ALINITY C RF. (ALINITY C RF.) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 2282R2019 SSA and manufactured by ABBOTT LABORATORIES DE MÉXICO, S.A. DE C.V.. The device was registered on December 13, 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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COFEPRIS Official Data
Clase I
2282R2019 SSA
ALINITY C RF.
COFEPRIS Analysis ID: 2282R2019 SSA
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Product Use / Uso del Producto
Spanish

EL ENSAYO ALINITY C RF SE UTILIZA PARA LA DETERMINACIÓN CUANTITATIVA DE FACTOR REUMATOIDE (FR) EN SUERO HUMANO EN EL ANALIZADOR ALINITY C. AGENTE DE DIAGNÓSTICO PARA USO IN VITRO. PARA USO EXCLUSIVO EN LABORATORIOS CLÍNICOS O DE GABINETES.

English

THE ALINITY C RF ASSAY IS USED FOR THE QUANTITATIVE DETERMINATION OF RHEUMATOID FACTOR (RF) IN HUMAN SERUM IN THE ALINITY C ANALYZER. DIAGNOSTIC AGENT FOR IN VITRO USE. FOR USE IN CLINICAL OR CABINET LABORATORIES ONLY.

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
ENSAYO PARA LA DETERMINACIÓN DE FACTOR REUMATOIDE (FR).
Trade Name (English)
ASSAY FOR THE DETERMINATION OF RHEUMATOID FACTOR (RF).
Registration Information
Analysis ID
2282R2019 SSA
Registration Date
December 13, 2019
Manufacturer / Fabricante
Name (English)
ABBOTT LABORATORIES DE MÉXICO, S.A. DE C.V.