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CANCER ANTIGEN 72-4 (CLIA) WIENER LAB. - COFEPRIS Registration 1505R2019 SSA

Access comprehensive regulatory information for CANCER ANTIGEN 72-4 (CLIA) WIENER LAB. (CANCER ANTIGEN 72-4 (CLIA) WIENER LAB.) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1505R2019 SSA and manufactured by REPRESENTACIONES LABIN MÉXICO, S.A. DE C.V.. The device was registered on July 30, 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 II
1505R2019 SSA
CANCER ANTIGEN 72-4 (CLIA) WIENER LAB.
COFEPRIS Analysis ID: 1505R2019 SSA
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Product Use / Uso del Producto
Spanish

INMUNOENSAYO QUIMIOLUMINISCENTE (CLIA) PARA LA DETERMINACIÓN CUANTITATIVA DE ANTÍGENO DE CÁNCER 72-4 (CA72-4) EN SUERO O PLASMA. AGENTE DE DIAGNÓSTICO PARA USO IN VITRO. PARA USO EXCLUSIVO EN LABORATORIOS CLÍNICOS O DE GABINETE.

English

CHEMOLUMINESCENT IMMUNOASSAY (CLIA) FOR THE QUANTITATIVE DETERMINATION OF CANCER ANTIGEN 72-4 (CA72-4) IN SERUM OR PLASMA. 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)
CANCER REACTIVO PARA LA DETERMINACIÓN DEL ANTÍGENO DE CÁNCER 72-4 (CA72-4).
Trade Name (English)
CANCER REAGENT FOR THE DETERMINATION OF CANCER ANTIGEN 72-4 (CA72-4).
Registration Information
Analysis ID
1505R2019 SSA
Registration Date
July 30, 2019
Manufacturer / Fabricante
Name (English)
REPRESENTACIONES LABIN MÉXICO, S.A. DE C.V.