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INFINITY TM LITHIUM (LI) REAGENT FOR BECKMAN COULTER AU® CHEMISTRY ANALYZERS - COFEPRIS Registration 770R2019 SSA

Access comprehensive regulatory information for INFINITY TM LITHIUM (LI) REAGENT FOR BECKMAN COULTER AU® CHEMISTRY ANALYZERS (INFINITY TM LITHIUM (LI) REAGENT FOR BECKMAN COULTER AU® CHEMISTRY ANALYZERS) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 770R2019 SSA and manufactured by BECKMAN COULTER DE MÉXICO, S.A. DE C.V.. The device was registered on April 12, 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
770R2019 SSA
INFINITY TM LITHIUM (LI) REAGENT FOR BECKMAN COULTER AU® CHEMISTRY ANALYZERS
COFEPRIS Analysis ID: 770R2019 SSA
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Product Use / Uso del Producto
Spanish

REACTIVO PARA LA DETERMINACIÓN CUANTITATIVA DE LA CONCENTRACIÓN DE LITIO EN SUERO Y PLASMA HUMANO PARA SU USO EN ANALIZADORES QUÍMICOS BECKMAN COULTER AU®. AGENTE DE DIAGNÓSTICO DE USO IN VITRO. PARA USO EXCLUSIVO EN LABORATORIO CLÍNICO O DE GABINETE.

English

REAGENT FOR THE QUANTITATIVE DETERMINATION OF LITHIUM CONCENTRATION IN HUMAN SERUM AND PLASMA FOR USE IN BECKMAN COULTER AU CHEMICAL ANALYZERS®. IN VITRO DIAGNOSTIC AGENT. FOR EXCLUSIVE USE IN CLINICAL LABORATORY OR CABINET.

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 DETERMINAR LITIO EN SUERO Y PLASMA HUMANO
Trade Name (English)
REAGENT FOR DETERMINING LITHIUM IN SERUM AND HUMAN PLASMA
Registration Information
Analysis ID
770R2019 SSA
Registration Date
April 12, 2019
Manufacturer / Fabricante
Name (English)
BECKMAN COULTER DE MÉXICO, S.A. DE C.V.