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ANTI-A, ANTI-B, ANTI-AB MONOCLONAL - COFEPRIS Registration 1647R2018 SSA

Access comprehensive regulatory information for ANTI-A, ANTI-B, ANTI-AB MONOCLONAL (ANTI-A, ANTI-B, ANTI-AB MONOCLONAL) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1647R2018 SSA and manufactured by INVESTIGACIÓN DIAGNÓSTICA, S.A. DE C.V.. The device was registered on June 28, 2018.

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
1647R2018 SSA
ANTI-A, ANTI-B, ANTI-AB MONOCLONAL
COFEPRIS Analysis ID: 1647R2018 SSA
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Product Use / Uso del Producto
Spanish

LOS REACTIVOS ANTI-A, ANTI-B, ANTI-AB MONOCLONAL, OCASIONARÁN AGLUTINACIÓN DIRECTA (AGLOMERACIÓN) DE GLÓBULOS ROJOS DE PRUEBA QUE PORTAN EL ANTÍGENO ABO CORRESPONDIENTE. SI NO HAY AGLUTINACIÓN, ES INDICATIVO DE AUSENCIA DEL CORRESPONDIENTE ANTÍGENO ABO.

English

THE ANTI-A, ANTI-B, ANTI-AB MONOCLONAL REAGENTS WILL CAUSE DIRECT AGGLUTINATION (AGGLOMERATION) OF TEST RED BLOOD CELLS CARRYING THE CORRESPONDING ABO ANTIGEN. IF THERE IS NO AGGLUTINATION, IT IS INDICATIVE OF THE ABSENCE OF THE CORRESPONDING ABO ANTIGEN.

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
REACTIVOS PARA LA DETERMINACIÓN DEL GRUPO SANGUÍNEO MONOCLONAL
Trade Name (English)
REAGENTS FOR THE DETERMINATION OF MONOCLONAL BLOOD GROUP
Registration Information
Analysis ID
1647R2018 SSA
Registration Date
June 28, 2018
Manufacturer / Fabricante
Name (English)
INVESTIGACIÓN DIAGNÓSTICA, S.A. DE C.V.