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EUROLINE ANTI-EBVPROFILE 2(IGG) - COFEPRIS Registration 703R2022 SSA

Access comprehensive regulatory information for EUROLINE ANTI-EBVPROFILE 2(IGG) (EUROLINE ANTI-EBVPROFILE 2(IGG)) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 703R2022 SSA and manufactured by INOCHEM S.A. DE C.V.. The device was registered on July 29, 2022.

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
703R2022 SSA
EUROLINE ANTI-EBVPROFILE 2(IGG)
COFEPRIS Analysis ID: 703R2022 SSA
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Product Use / Uso del Producto
Spanish

SISTEMA DE PRUEBA PARA LA DETERMINACIÓNCUALITATIVAINVITRO(IVD)DEANTICUERPOSHUMANOSDELACLASEDEINMUNOGLOBULINAIGGCONTRA5ANTÍGENOSDEEBV:VCAGP125,VCAP19,EBNA-1,P22YEA-DENSUEROOPLASMA,PARAAPOYARELDIAGNÓSTICODEINFECCIONESCON VIRUS DE EPSTEIN-BARR (MONONUCLEOSISINFECCIOSA, SÍNDROME DE BURKITT, CARCINOMANASOFARÍNGEO). AGENTE DE DIAGNÓSTICO DE USO INVITRO. PARAUSOEXCLUSIVOENLABORATORIOSCLÍNICOSO DE GABINETES.

English

TEST SYSTEM FOR QUALITATIVE DETERMINATION (IVD)DEANTICUERPOSHUMANOSDELACLASEDEINMUNOGLOBULINAIGGCONTRA5ANTÍGENOSDEEBV:VCAGP125,VCAP19,EBNA-1,P22YEA-SERUM-DENSERUM OR PLASMA,TO SUPPORT THE DIAGNOSIS OF EPSTEIN-BARR VIRUS INFECTIONS (INFECTIOUS MONONUCLEOSIS, BURKITT SYNDROME, NASOPHARYNGEAL CARCINOMA). DIAGNOSTIC AGENT FOR INVITRO USE. FOR EXCLUSIVE USE IN CLINICAL LABORATORIES OR CABINETS.

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DEDIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
SISTEMADEPRUEBAPARALADETERMINACIÓN DEANTICUERPOS CONTRA 5ANTÍGENOS DEL VIRUS DEEPSTEIN BARR.
Trade Name (English)
TEST SYSTEM FOR THE DETERMINATION OF ANTIBODIES AGAINST 5 ANTIGENS OF THE DEEPSTEIN BARR VIRUS.
Registration Information
Analysis ID
703R2022 SSA
Registration Date
July 29, 2022
Manufacturer / Fabricante
Name (Spanish)
INOCHEM S.A. DE C.V.
Name (English)
INOCHEM S.A. DE C.V.