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GPIIB/IIIA ANTAGONIST REAGENT. - COFEPRIS Registration 1457R2020 SSA

Access comprehensive regulatory information for GPIIB/IIIA ANTAGONIST REAGENT. (GPIIB/IIIA ANTAGONIST REAGENT.) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1457R2020 SSA and manufactured by PRODUCTOS ROCHE, S.A. DEC.V.. The device was registered on October 23, 2020.

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
1457R2020 SSA
GPIIB/IIIA ANTAGONIST REAGENT.
COFEPRIS Analysis ID: 1457R2020 SSA
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Product Use / Uso del Producto
Spanish

GPIIB/IIIA ANTAGONIST REAGENT SIRVE COMOCONTROLDECALIDADDELASPRUEBASDELAFUNCIÓN PLAQUETARIA EN MUESTRAS DESANGRE TOTAL PROCESADAS EN LOSANALIZADORESROCHE.ELREACTIVOSEUTILIZAEN COMBINACIÓN CON EL REACTIVOACTIVADORTRAPTESTDEROCHE. LAADICIÓNDELREACTIVOGPIIB/IIIAANTAGONISTREAGENTA UNA MUESTRA DE SANGRE PROVOCA UNAAGREGACIÓN MUY REDUCIDA EN LA PRUEBATRAPTEST. AGENTE DE DIAGNÓSTICO PARAUSO IN VITRO. PARA USO EXCLUSIVO ENLABORATORIOS CLÍNICOS O DE GABINETES.

English

GPIIB/IIIA ANTAGONIST REAGENT SERVES AS A QUALITY CONTROL OF PLATELET FUNCTION TESTS IN WHOLE BLOOD SAMPLES PROCESSED IN ROCHE ANALYSERS. THE REAGENTS ARE USED IN COMBINATION WITH THE REAGENTACTIVATORTRAPTESTDEROCHE. THE ADDITION OF THE REAGENT GPIIB/IIIAANTAGONISTREAGENTA A BLOOD SAMPLE CAUSES A VERY REDUCED AGGREGATION IN THE TRAPTEST. DIAGNOSTIC AGENT FOR IN VITRO USE. FOR USE ONLY IN CLINICAL LABORATORIES OR CABINETS.

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)
REACTIVO CONTROL.
Trade Name (English)
REACTIVE CONTROL.
Registration Information
Analysis ID
1457R2020 SSA
Registration Date
October 23, 2020
Manufacturer / Fabricante
Name (English)
PRODUCTOS ROCHE, S.A. DEC.V.