Mexico COFEPRIS registration 2448R2018 SSA

FINECARE™ CK-MB RAPID QUANTITATIVE TEST

EN: FINECARE™ CK-MB RAPID QUANTITATIVE TEST
Mexico flagMexico·Clase I·III. DIAGNOSTIC AGENTS·DISTRIBUIDORA QUÍMICA INTEGRAL, S.A. DE C.V.·Registered October 24, 2018
Product Use / Uso del Producto
Spanish

LA PRUEBA CUANTITATIVA RÁPIDA DE CK-MB DE THE FINECARETM ES UN INMUNOENSAYO DE FLUORESCENCIA UTILIZADO JUNTO CON EL SISTEMA FIA, PARA LA DETERMINACIÓN CUANTITATIVA DE LA CREATINCINASA-MB (CK-MB) EN SANGRE COMPLETA, SUERO O PLASMA HUMANO. SOLO PARA USO EN

English

THE FINECARETM QUANTITATIVE RAPID CK-MB TEST IS A FLUORESCENCE IMMUNOASSAY USED IN CONJUNCTION WITH THE FIA SYSTEM, FOR THE QUANTITATIVE DETERMINATION OF CREATINE KINASE-MB (CK-MB) IN WHOLE BLOOD, SERUM OR HUMAN PLASMA. FOR USE IN

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)
CARTUCHO DE PRUEBA PARA LA CUANTIFICACION DE CK-MB
Trade Name (English)
TEST CARTRIDGE FOR QUANTIFICATION OF CK-MB
Registration information
Analysis ID
2448R2018 SSA
Registration Date
October 24, 2018
Manufacturer / Fabricante
Name (English)
DISTRIBUIDORA QUÍMICA INTEGRAL, S.A. DE C.V.
About this record

Access comprehensive regulatory information for FINECARE™ CK-MB RAPID QUANTITATIVE TEST (FINECARE™ CK-MB RAPID QUANTITATIVE TEST) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 2448R2018 SSA and manufactured by DISTRIBUIDORA QUÍMICA INTEGRAL, S.A. DE C.V.. The device was registered on October 24, 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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