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KIT ALFA-1 ANTITRIPSINA OPTILITE® - COFEPRIS Registration 753R2019 SSA

Access comprehensive regulatory information for KIT ALFA-1 ANTITRIPSINA OPTILITE® (ALPHA-1 ANTITRYPSIN KIT 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 753R2019 SSA and manufactured by INSUMOS PARA LA SALUD, S.A. DE C.V.. The device was registered on April 10, 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
753R2019 SSA
KIT ALFA-1 ANTITRIPSINA OPTILITE®
COFEPRIS Analysis ID: 753R2019 SSA
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Product Use / Uso del Producto
Spanish

EL KIT ALFA-1 ANTITRIPSINA OPTILITE® ESTÁ DISEÑADO PARA LA CUANTIFICACIÓN IN VITRO DE ALFA-1 ANTITRIPSINA EN SUERO O EN PLASMA OBTENIDO CON HEPARINA LITIO O EDTA, EN EL ANALIZADOR OPTILITE® DE BINDING SITE. LA DETERMINACIÓN DE ALFA-1 ANTITRIPSINA ES ÚTIL

English

THE ALPHA-1 ANTITRYPSIN OPTILITE KIT IS DESIGNED FOR IN VITRO QUANTIFICATION OF ALPHA-1 ANTITRYPSIN IN SERUM OR PLASMA OBTAINED WITH LITHIUM HEPARIN OR EDTA, IN THE BINDING SITE OPTILITE®® ANALYZER. DETERMINATION OF ALPHA-1 ANTITRYPSIN IS USEFUL

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 ALFA-1 ANTITRIPSINA
Trade Name (English)
REAGENT FOR THE DETERMINATION OF ALPHA-1 ANTITRYPSIN
Registration Information
Analysis ID
753R2019 SSA
Registration Date
April 10, 2019
Manufacturer / Fabricante
Name (English)
INSUMOS PARA LA SALUD, S.A. DE C.V.