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ONESTEP ROTAVIRUS ANTIGEN RAPICARD INSTA TEST - COFEPRIS Registration 1869R2018 SSA

Access comprehensive regulatory information for ONESTEP ROTAVIRUS ANTIGEN RAPICARD INSTA TEST (ONESTEP ROTAVIRUS ANTIGEN RAPICARD INSTA TEST) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1869R2018 SSA and manufactured by DIAGMEX, S.A. DE C.V.. The device was registered on August 02, 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 I
1869R2018 SSA
ONESTEP ROTAVIRUS ANTIGEN RAPICARD INSTA TEST
COFEPRIS Analysis ID: 1869R2018 SSA
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Product Use / Uso del Producto
Spanish

ENSAYO INMUNOCROMATOGRรFICO CUALITATIVO IN VITRO PARA LA DETECCIร“N DE ANTรGENOS DE ROTAVIRUS EN MUESTRAS DE HECES HUMANAS.

English

IN VITRO QUALITATIVE IMMUNOCHROMATOGRAPHIC ASSAY FOR THE DETECTION OF ROTAVIRUS ANTIGENS IN HUMAN STOOL SAMPLES.

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DE DIAGNร“STICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
ENSAYO PARA LA DETECCIร“N DEL ANTรGENO DE ROTAVIRUS EN MUESTRAS DE HECES HUMANAS
Trade Name (English)
ASSAY FOR THE DETECTION OF ROTAVIRUS ANTIGEN IN HUMAN STOOL SAMPLES
Registration Information
Analysis ID
1869R2018 SSA
Registration Date
August 02, 2018
Manufacturer / Fabricante
Name (Spanish)
DIAGMEX, S.A. DE C.V.
Name (English)
DIAGMEX, S.A. DE C.V.