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KIT HAPTOGLOBINA OPTILITE® - COFEPRIS Registration 1916R2018 SSA

Access comprehensive regulatory information for KIT HAPTOGLOBINA OPTILITE® (KIT HAPTOGLOBINA 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 1916R2018 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
1916R2018 SSA
KIT HAPTOGLOBINA OPTILITE®
COFEPRIS Analysis ID: 1916R2018 SSA
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Product Use / Uso del Producto
Spanish

EL KIT HAPTOGLOBINA OPTILITE® ESTÁ DISEÑADO PARA LA CUANTIFICACIÓN IN VITRO DE HAPTOGLOBINA EN SUERO O EN PLASMA OBTENIDO CON HEPARINA LITIO O EDTA EN EL ANALIZADOR OPTILITE® DE BINDING SITE. LA DETERMINACIÓN DE HAPTOGLOBINA ES ÚTIL EN EL DIAGNÓSTICO DE E

English

THE OPTILITE HAPTOGLOBIN KIT IS DESIGNED FOR IN VITRO QUANTIFICATION OF HAPTOGLOBIN IN SERUM OR PLASMA OBTAINED WITH LITHIUM HEPARIN OR EDTA IN BINDING SITE'S OPTILITE®® ANALYZER. THE DETERMINATION OF HAPTOGLOBIN IS USEFUL IN THE DIAGNOSIS OF

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 HAPTOGLOBINA
Trade Name (English)
REAGENT FOR THE DETERMINATION OF HAPTOGLOBIN
Registration Information
Analysis ID
1916R2018 SSA
Registration Date
August 06, 2018
Manufacturer / Fabricante
Name (English)
INSUMOS PARA LA SALUD, S.A. DE C.V.