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IMMUNOLOGY KIT CREATINE KINASE MB MINDRAY - COFEPRIS Registration 1528R2018 SSA

Access comprehensive regulatory information for IMMUNOLOGY KIT CREATINE KINASE MB MINDRAY (IMMUNOLOGY KIT CREATINE KINASE MB MINDRAY) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1528R2018 SSA and manufactured by MINDRAY MEDICAL Mร‰XICO, S. DE R.L. DE C.V.. The device was registered on June 13, 2018.

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
1528R2018 SSA
IMMUNOLOGY KIT CREATINE KINASE MB MINDRAY
COFEPRIS Analysis ID: 1528R2018 SSA
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Product Use / Uso del Producto
Spanish

IMMUNOLOGY KIT CREATINE KINASE MB MINDRAY ES UN KIT DE REACTIVOS PARA LA DETERMINACIร“N CUANTITATIVA DE CREATINCINASA MB (CK-MB) A TRAVร‰S DE UN INMUNOENSAYO DE QUIMIOLUMINISCENCIA (CLIA) EN PLASMA O SUERO HUMANOS. ESTE KIT SE UTILIZA EXCLUSIVAMENTE EN LOS

English

IMMUNOLOGY KIT CREATINE KINASE MB MINDRAY IS A REAGENT KIT FOR THE QUANTITATIVE DETERMINATION OF CREATINE KINASE MB (CK-MB) THROUGH A CHEMILUMINESCENCE IMMUNOASSAY (CLIA) IN HUMAN PLASMA OR SERUM. THIS KIT IS USED EXCLUSIVELY IN THE

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DE DIAGNร“STICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
KIT PARA LA DETERMINACIร“N CUANTITATIVA DE CREATINCINASA MB
Trade Name (English)
KIT FOR THE QUANTITATIVE DETERMINATION OF CREATINE KINASE MB
Registration Information
Analysis ID
1528R2018 SSA
Registration Date
June 13, 2018
Manufacturer / Fabricante
Name (English)
MINDRAY MEDICAL MEXICO, S. DE R.L. DE C.V.