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ANTI-D (IGM / IGG) - COFEPRIS Registration 1298R2018 SSA

Access comprehensive regulatory information for ANTI-D (IGM / IGG) (ANTI-D (IGM / IGG)) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1298R2018 SSA and manufactured by INVESTIGACIÓN DIAGNÓSTICA, S.A. DE C.V.. The device was registered on June 01, 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
1298R2018 SSA
ANTI-D (IGM / IGG)
COFEPRIS Analysis ID: 1298R2018 SSA
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Product Use / Uso del Producto
Spanish

EL REACTIVO MONOCLONAL ANTI-D (IGM/IGG) PARA DETERMINACIÓN DE GRUPO SANGUÍNEO, OCASIONARÁ AGLUTINACIÓN DIRECTA (AGLOMERACIÓN) DE LOS GLÓBULOS ROJOS DE PRUEBA QUE PORTAN EL ANTÍGENO D Y LA AGLUTINACIÓN INDIRECTA DE LOS GLÓBULOS ROJOS DE PRUEBA QUE SON CATE

English

THE ANTI-D MONOCLONAL REAGENT (IGM/IGG) FOR BLOOD GROUPING DETERMINATION WILL CAUSE DIRECT AGGLUTINATION (AGGLOMERATION) OF TEST RED BLOOD CELLS CARRYING THE D ANTIGEN AND INDIRECT AGGLUTINATION OF TEST RED BLOOD CELLS THAT ARE

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)
REACTIVO MONOCLONAL PARA LA DETERMINACIÓN DE GRUPO SANGUÍNEO ANTI-D (IGM / IGG)
Trade Name (English)
MONOCLONAL REAGENT FOR ANTI-D BLOOD GROUP DETERMINATION (IGM/IGG)
Registration Information
Analysis ID
1298R2018 SSA
Registration Date
June 01, 2018
Manufacturer / Fabricante
Name (English)
INVESTIGACIÓN DIAGNÓSTICA, S.A. DE C.V.