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CERTUM DIAGNOSTICS ZIKA NS1 RAPID TEST CASSETTE - COFEPRIS Registration 1697R2019 SSA

Access comprehensive regulatory information for CERTUM DIAGNOSTICS ZIKA NS1 RAPID TEST CASSETTE (CERTUM DIAGNOSTICS ZIKA NS1 RAPID TEST CASSETTE) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1697R2019 SSA and manufactured by KABLA COMERCIAL, S.A. DE C.V.. The device was registered on August 22, 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 II
1697R2019 SSA
CERTUM DIAGNOSTICS ZIKA NS1 RAPID TEST CASSETTE
COFEPRIS Analysis ID: 1697R2019 SSA
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Product Use / Uso del Producto
Spanish

ES UN INMUNOENSAYO CROMATOGRรFICO PARA LA DETECCIร“N CUALITATIVA DEL ANTรGENO NS1 DEL VIRUS DEL ZIKA EN SANGRE, SUERO O PLASMA HUMANOS COMO AUXILIAR EN EL DIAGNร“STICO DE INFECCIONES POR ZIKA. PARA USO EXCLUSIVO EN LABORATORIOS CLรNICOS O DE GABINETES. AG

English

IT IS A CHROMATOGRAPHIC IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF ZIKA VIRUS NS1 ANTIGEN IN HUMAN BLOOD, SERUM OR PLASMA AS AN AID IN THE DIAGNOSIS OF ZIKA INFECTIONS. FOR USE IN CLINICAL OR CABINET LABORATORIES ONLY. AG

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
III. AGENTES DE DIAGNร“STICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
PRUEBA RรPIDA PARA LA DETECCIร“N CUALITATIVA DE ANTรGENO NS1 DEL VIRUS DEL ZIKA
Trade Name (English)
RAPID TEST FOR QUALITATIVE DETECTION OF ZIKA VIRUS NS1 ANTIGEN
Registration Information
Analysis ID
1697R2019 SSA
Registration Date
August 22, 2019
Manufacturer / Fabricante
Name (English)
KABLA COMERCIAL, S.A. DE C.V.