Mexico COFEPRIS registration 1139R2018 SSA

DAT IGG-DILUTION

EN: DAT IGG-DILUTION
Mexico flagMexico·Clase I·III. DIAGNOSTIC AGENTS·BIO-RAD, S.A.·Registered May 17, 2018
Product Use / Uso del Producto
Spanish

DETERMINACIÓN DE IGG. LA TARJETA ID-CARD “DAT IGG-DILUTION” PROPORCIONA UNA INDICACIÓN DE LA SIGNIFICACIÓN CLÍNICA DE UNA PRUEBA DE ANTIGLOBULINA DIRECTA POSITIVA. AGENTES DE DIAGNÓSTICO. PARA USO EXCLUSIVO EN LABORATORIOS CLÍNICOS O DE GABINETE.

English

DETERMINATION OF IGG. THE ID-CARD "DAT IGG-DILUTION" PROVIDES AN INDICATION OF THE CLINICAL SIGNIFICANCE OF A POSITIVE DIRECT ANTIGLOBULIN TEST. DIAGNOSTIC AGENTS. FOR USE IN CLINICAL OR CABINET LABORATORIES ONLY.

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)
ANTICUERPOS ANTI-IGG (DE CONEJO)
Trade Name (English)
ANTI-IGG ANTIBODIES (RABBIT)
Registration information
Analysis ID
1139R2018 SSA
Registration Date
May 17, 2018
Manufacturer / Fabricante
Name (Spanish)
BIO-RAD, S.A.
Name (English)
BIO-RAD, S.A.
About this record

Access comprehensive regulatory information for DAT IGG-DILUTION (DAT IGG-DILUTION) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1139R2018 SSA and manufactured by BIO-RAD, S.A.. The device was registered on May 17, 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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