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NEPHSTAR® SSA KIT (SERUMAMYLOID A). - COFEPRIS Registration 1313R2021 SSA

Access comprehensive regulatory information for NEPHSTAR® SSA KIT (SERUMAMYLOID A). (NEPHSTAR® SSA KIT (SERUMAMYLOID A).) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1313R2021 SSA and manufactured by KABLACOMERCIAL,S.A.DE C.V.. The device was registered on January 09, 2021.

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
1313R2021 SSA
NEPHSTAR® SSA KIT (SERUMAMYLOID A).
COFEPRIS Analysis ID: 1313R2021 SSA
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Product Use / Uso del Producto
Spanish

ELNEPHSTAR®SSAKIT(SERUMAMYLOIDA),SE UTILIZA EN EL SISTEMADE ANÁLISIS DEPROTEÍNAS NEPHSTAR PARA LADETERMINACIÓNCUANTITATIVADEAMILOIDEA SÉRICO (SAA) EN SUERO HUMANO. ELNEPHSTAR®SSACONTROL, ESTÁDISEÑADOPARA SU USO CON LOS SISTEMAS DEINMUNOENSAYONEFELOMÉTRICOGOLDSITEEN EL CONTROL DE CALIDAD DE LOSENSAYOSDESAA. AGENTEDEDIAGNÓSTICOPARAUSOINVITRO. PARAUSOEXCLUSIVOEN LABORATORIOS CLÍNICOS O DE GABINETE.

English

NEPHSTAR SSAKIT (SERUMAMYLOIDA) IS USED IN THE NEPHSTAR®PROTEIN ANALYSIS SYSTEM FOR THE QUANTITATIVE DETERMINATION OF SERUM AMYLOID (SAA) IN HUMAN SERUM. THE NEPHSTAR®SSACONTROL IS DESIGNED FOR USE WITH GOLDSITE NEPHELOMETRIC IMMUNOASSAY SYSTEMS IN THE QUALITY CONTROL OF DESAA ASSAYS. DIAGNOSTICAGENTFORUSEINVITRO. FOR EXCLUSIVE USE IN CLINICAL OR CABINET LABORATORIES.

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)
KIT PARA LA DETERMINACIÓN DE SUEROAMILOIDE A.
Trade Name (English)
KIT FOR THE DETERMINATION OF SERUM AMYLOID A.
Registration Information
Analysis ID
1313R2021 SSA
Registration Date
January 09, 2021
Manufacturer / Fabricante
Name (English)
KABLACOMERCIAL,S.A.DE C.V.