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CERTUM CHIKUNGUNYA IGG/IGM - COFEPRIS Registration 761R2019 SSA

Access comprehensive regulatory information for CERTUM CHIKUNGUNYA IGG/IGM (CERTUM CHIKUNGUNYA IGG/IGM) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 761R2019 SSA and manufactured by KABLA COMERCIAL, S.A. DE C.V.. The device was registered on April 11, 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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COFEPRIS Official Data
Clase I
761R2019 SSA
CERTUM CHIKUNGUNYA IGG/IGM
COFEPRIS Analysis ID: 761R2019 SSA
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Product Use / Uso del Producto
Spanish

LA PRUEBA CERTUM CHIKUNGUNYA IGG/IGM ES UN RรPIDO INMUNOENSAYO CROMATOGRรFICO PARA LA DETECCIร“N CUALITATIVA DE ANTICUERPOS IGG E IGM CONTRA CHIKUNGUNYA EN MUESTRAS HUMANAS DE SANGRE ENTERA, SUERO O PLASMA. EL ENSAYO SE PRETENDE COMO UNA PRUEBA DE CRIBADO

English

THE CERTUM CHIKUNGUNYA IGG/IGM TEST IS A RAPID CHROMATOGRAPHIC IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF IGG AND IGM ANTIBODIES AGAINST CHIKUNGUNYA IN HUMAN WHOLEBLOOD, SERUM OR PLASMA SAMPLES. THE ASSAY IS INTENDED AS A SCREENING TEST

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)
PRUEBA PARA LA DETECCIร“N CUALITATIVA DE ANTICUERPOS IGG/IGM DE CHINKUNGUNYA
Trade Name (English)
TEST FOR QUALITATIVE DETECTION OF CHINKUNGUNYA IGG/IGM ANTIBODIES
Registration Information
Analysis ID
761R2019 SSA
Registration Date
April 11, 2019
Manufacturer / Fabricante
Name (English)
KABLA COMERCIAL, S.A. DE C.V.