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KIT CERULOPLASMINA OPTILITE® - COFEPRIS Registration 1918R2018 SSA

Access comprehensive regulatory information for KIT CERULOPLASMINA OPTILITE® (KIT CERULOPLASMINA OPTILITE®) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1918R2018 SSA and manufactured by INSUMOS PARA LA SALUD, S.A. DE C.V.. The device was registered on August 06, 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
1918R2018 SSA
KIT CERULOPLASMINA OPTILITE®
COFEPRIS Analysis ID: 1918R2018 SSA
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Product Use / Uso del Producto
Spanish

EL KIT CERULOPLASMINA OPTILITE® TIENE COMO OBJETIVO LA CUANTIFICACIÓN IN VITRO DE LA CERULOPLASMINA EN SUERO Y EN PLASMA OBTENIDA CON HEPARINA-LITIO, USANDO EL ANALIZADOR OPTILITE® DE BINGING SITE COMO AYUDA EN EL DIAGNÓSTICO DE TRASTORNOS EN EL METABOLIS

English

THE CERULOPLASMIN OPTILITE KIT AIMS AT THE IN VITRO QUANTIFICATION OF CERULOPLASMIN IN SERUM AND PLASMA OBTAINED WITH HEPARIN-LITHIUM, USING THE OPTILITE®® ANALYZER OF BINGING SITE AS AN AID IN THE DIAGNOSIS OF DISORDERS IN THE METABOLIS

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 CERULOPLASMINA
Trade Name (English)
REAGENT FOR THE DETERMINATION OF CERULOPLASMIN
Registration Information
Analysis ID
1918R2018 SSA
Registration Date
August 06, 2018
Manufacturer / Fabricante
Name (English)
INSUMOS PARA LA SALUD, S.A. DE C.V.