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CERTUM D-DIMER RAPID TEST CASSETTE - COFEPRIS Registration 1773R2019 SSA

Access comprehensive regulatory information for CERTUM D-DIMER RAPID TEST CASSETTE (CERTUM D-DIMER 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 1773R2019 SSA and manufactured by KABLA COMERCIAL, S.A. DE C.V.. The device was registered on August 29, 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
1773R2019 SSA
CERTUM D-DIMER RAPID TEST CASSETTE
COFEPRIS Analysis ID: 1773R2019 SSA
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Product Use / Uso del Producto
Spanish

LA PRUEBA CERTUM D-DIMER RAPID TEST CASSETTE ES UN INMUNOENSAYO CROMATOGRรFICO RรPIDO PARA LA DETECCIร“N CUALITATIVA DE DรMERO-D HUMANO EN SANGRE ENTERA O PLASMA COMO AYUDA EN EL DIAGNร“STICO DE LA COAGULOPATรA INTRAVASCULAR DISEMINADA (DIC), TROMBOSIS VENO

English

THE CERTUM D-DIMER RAPID TEST CASSETTE IS A RAPID CHROMATOGRAPHIC IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF HUMAN D-DIMER IN WHOLE BLOOD OR PLASMA AS AN AID IN THE DIAGNOSIS OF DISSEMINATED INTRAVASCULAR COAGULOPATHY (DIC), VENO THROMBOSIS.

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 DรMERO-D
Trade Name (English)
RAPID TEST FOR QUALITATIVE DETECTION OF D-DIMER
Registration Information
Analysis ID
1773R2019 SSA
Registration Date
August 29, 2019
Manufacturer / Fabricante
Name (English)
KABLA COMERCIAL, S.A. DE C.V.