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DIMENSION® CLINICAL CHEMISTRY SYSTEM COC FLEX® REAGENT CARTRIDGE - COFEPRIS Registration 543R2019 SSA

Access comprehensive regulatory information for DIMENSION® CLINICAL CHEMISTRY SYSTEM COC FLEX® REAGENT CARTRIDGE (DIMENSION® CLINICAL CHEMISTRY SYSTEM COC FLEX® REAGENT CARTRIDGE) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 543R2019 SSA and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L. DE C.V.. The device was registered on March 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
543R2019 SSA
DIMENSION® CLINICAL CHEMISTRY SYSTEM COC FLEX® REAGENT CARTRIDGE
COFEPRIS Analysis ID: 543R2019 SSA
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Product Use / Uso del Producto
Spanish

EL CARTUCHO DE REACTIVOS FLEX® DE COC UTILIZADO EN EL SISTEMA DE QUÍMICA CLÍNICA DIMENSION® PROPORCIONA LOS REACTIVOS NECESARIOS PARA UNA PRUEBA DE DIAGNÓSTICO IN VITRO PARA LA DETERMINACIÓN CUALITATIVA Y SEMICUANTITATIVA DE LA BENZOILECGONINA (METABOLITO

English

THE COC FLEX® REAGENT CARTRIDGE USED IN THE DIMENSION® CLINICAL CHEMISTRY SYSTEM PROVIDES THE REAGENTS NEEDED FOR AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVE AND SEMI-QUANTITATIVE DETERMINATION OF BENZOYLECGONINE (METABOLITE

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)
PRUEBA PARA DETERMINACIÓN DE BENZOILECGONINA
Trade Name (English)
BENZOYLECGONINE TEST
Registration Information
Analysis ID
543R2019 SSA
Registration Date
March 14, 2019
Manufacturer / Fabricante
Name (English)
SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L. DE C.V.