Mexico COFEPRIS registration 1305R2019 SSA

FX

EN: FX
Mexico flagMexico·Clase I·III. DIAGNOSTIC AGENTS·PRODUCTOS ROCHE, S.A. DE C.V.·Registered July 15, 2019
Product Use / Uso del Producto
Spanish

PLASMA HUMANO DEFICIENTE DE FACTOR X (POR INMUNOABSORCIÓN) PARA LA DETERMINACIÓN CUANTITATIVA DE LA ACTIVIDAD DEL FACTOR X EN PLASMA CITRATADO BASADO EN LA DETERMINACIÓN DEL TIEMPO DE PROTROMBINA (TP) EN LOS ANALIZADORES ROCHE. AGENTE DE DIAGNÓSTICO PA

English

HUMAN PLASMA DEFICIENT IN FACTOR X (BY IMMUNOABSORPTION) FOR THE QUANTITATIVE DETERMINATION OF FACTOR X ACTIVITY IN CITRATE PLASMA BASED ON THE DETERMINATION OF PROTHROMBIN TIME (TP) IN ROCHE ANALYZERS. PA DIAGNOSTIC AGENT

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 PARA LA DETERMINACIÓN DE LA ACTIVIDAD DEL FACTOR X
Trade Name (English)
REAGENT FOR THE DETERMINATION OF FACTOR X ACTIVITY
Registration information
Analysis ID
1305R2019 SSA
Registration Date
July 15, 2019
Manufacturer / Fabricante
Name (English)
PRODUCTOS ROCHE, S.A. DE C.V.
About this record

Access comprehensive regulatory information for FX (FX) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1305R2019 SSA and manufactured by PRODUCTOS ROCHE, S.A. DE C.V.. The device was registered on July 15, 2019.

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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