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ALBT2 - COFEPRIS Registration 1564R2020 SSA

Access comprehensive regulatory information for ALBT2 (ALBT2) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1564R2020 SSA and manufactured by PRODUCTOS ROCHE, S.A. DEC.V.. The device was registered on November 26, 2020.

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
1564R2020 SSA
ALBT2
COFEPRIS Analysis ID: 1564R2020 SSA
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Product Use / Uso del Producto
Spanish

LA PRUEBA ALBT2, SE UTILIZA PARA LADETERMINACIÓN CUANTITATIVA DE LAALBÚMINA EN ORINA, SUERO, PLASMA Y LCR(COCIENTE ALBÚMINA EN LCR/SUERO),HUMANOS EN LOS SISTEMAS ROCHE/HITACHICOBASC. AGENTEDEDIAGNÓSTICOPARAUSOIN VITRO. PARA USO EXCLUSIVO ENLABORATORIOS CLÍNICOS O DE GABINETES.

English

THE ALBT2 TEST IS USED FOR THE QUANTITATIVE DETERMINATION OF ALBUMIN IN URINE, SERUM, PLASMA AND CSF (ALBUMIN RATIO IN CSF / SERUM), HUMANS IN THE ROCHE / HITACHICOBASC SYSTEMS. DIAGNOSTIC AGENTFORUSE in VITRO. FOR USE ONLY IN CLINICAL LABORATORIES OR CABINETS.

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 INMUNOTURBIDIMETRICAPARA DETERMINACIÓNCUANTITATIVA DE ALBUMINA ENSUERO PLASMA ORINA Y LIQU
Trade Name (English)
IMMUNOTURBIDIMETRIC TEST FOR QUANTITATIVE DETERMINATION OF ALBUMIN SERUM PLASMA URINE AND LIQU
Registration Information
Analysis ID
1564R2020 SSA
Registration Date
November 26, 2020
Manufacturer / Fabricante
Name (English)
PRODUCTOS ROCHE, S.A. DEC.V.