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CREATINE KINASE MB (CLIA) WIENER LAB. - COFEPRIS Registration 1613R2019 SSA

Access comprehensive regulatory information for CREATINE KINASE MB (CLIA) WIENER LAB. (CREATINE KINASE MB (CLIA) WIENER LAB.) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1613R2019 SSA and manufactured by REPRESENTACIONES LABIN MÉXICO, S.A. DE C.V.. The device was registered on August 14, 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
1613R2019 SSA
CREATINE KINASE MB (CLIA) WIENER LAB.
COFEPRIS Analysis ID: 1613R2019 SSA
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Product Use / Uso del Producto
Spanish

INMUNOENSAYO QUIMIOLUMINISCENTE (CLIA) PARA LA DETERMINACIÓN CUANTITATIVA DE ISOENZIMA MB DE CREATINA KINASA (CK-MB) 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 CREATINE KINASE ISOENZYME MB (CK-MB) 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 I
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
REACTIVO PARA LA DETERMINACIÓN DE LA ISOENZIMA CREATINA KINASA MB (CK-MB).
Trade Name (English)
REAGENT FOR THE DETERMINATION OF THE ISOENZYME CREATINE KINASE MB (CK-MB).
Registration Information
Analysis ID
1613R2019 SSA
Registration Date
August 14, 2019
Manufacturer / Fabricante
Name (English)
REPRESENTACIONES LABIN MÉXICO, S.A. DE C.V.