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BIOSYNEX MICRO ALBUMIN (SEMI-QUANTITATIVE). - COFEPRIS Registration 481R2019 SSA

Access comprehensive regulatory information for BIOSYNEX MICRO ALBUMIN (SEMI-QUANTITATIVE). (BIOSYNEX MICRO ALBUMIN (SEMI-QUANTITATIVE).) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 481R2019 SSA and manufactured by PHARMACUR, S.A. DE C.V.. The device was registered on March 11, 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 II
481R2019 SSA
BIOSYNEX MICRO ALBUMIN (SEMI-QUANTITATIVE).
COFEPRIS Analysis ID: 481R2019 SSA
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Product Use / Uso del Producto
Spanish

PRUEBA RรPIDA INMUNO-CROMATOGRรFICA PARA LA DETECCIร“N SEMI-CUANTITATIVA DE PEQUEร‘AS CANTIDADES DE ALBรšMINA EN LA ORINA HUMANA. AGENTE DE DIAGNร“STICO PARA USO IN VITRO. PARA USO EXCLUSIVO EN LABORATORIOS CLรNICOS O DE GABINETE.

English

RAPID IMMUNOCHROMATOGRAPHIC TEST FOR SEMI-QUANTITATIVE DETECTION OF SMALL AMOUNTS OF ALBUMIN IN HUMAN URINE. DIAGNOSTIC AGENT FOR IN VITRO USE. FOR USE IN CLINICAL OR CABINET LABORATORIES ONLY.

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
III. AGENTES DE DIAGNร“STICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
PRUEBA RรPIDA PARA LA DETECCIร“N SEMI-CUANTITATIVA DE MICROALBUMINARIA EN LA ORINA HUMANA.
Trade Name (English)
RAPID TEST FOR SEMI-QUANTITATIVE DETECTION OF MICROALBUMINARIA IN HUMAN URINE.
Registration Information
Analysis ID
481R2019 SSA
Registration Date
March 11, 2019
Manufacturer / Fabricante
Name (English)
PHARMACUR, S.A. DE C.V.