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HUBI D-DIMER - COFEPRIS Registration 1403R2021 SSA

Access comprehensive regulatory information for HUBI D-DIMER (HUBI D-DIMER) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1403R2021 SSA and manufactured by KABLACOMERCIAL,S.A.DE C.V.. The device was registered on September 13, 2021.

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
1403R2021 SSA
HUBI D-DIMER
COFEPRIS Analysis ID: 1403R2021 SSA
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Product Use / Uso del Producto
Spanish

HUBI D-DIMER ES UNAPRUEBARÁPIDADEPUNTODEATENCIÓNBASADAENENSAYODEINMUNOCROMATOGRAFÍA QUE SE UTILIZACON EL HUBI-QUANPRO PARA LADETERMINACIÓN DE PRODUCTOS DEDEGRADACIÓN DE LA FIBRINAENTRECRUZADA (DÍMERO D) EN MUESTRASDE SANGRE ENTERA O PLASMAANTICOAGULADAS CON CITRATO O EDTA.PARA DIAGNÓSTICO IN VITRO.

English

HUBI D-DIMER IS A RAPID POINT-OF-CARE TEST BASED ON IMMUNOCHROMATOGRAPHY ASSAY USED WITH THE HUBI-QUANPRO FOR THE DETERMINATION OF CROSS-LINKED FIBRIN DEGRADATION PRODUCTS (D-DIMER) IN WHOLE BLOOD OR PLASMA SAMPLES ANTICOAGULATED WITH CITRATE OR EDTA. FOR IN VITRO DIAGNOSTICS.

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
PRUEBA INMUNOCROMATOGRÁFICA PARALA DETERMINACIÓN CUANTITATIVA DEDÍMERO-D
Trade Name (English)
IMMUNOCHROMATOGRAPHIC TEST FOR THE QUANTITATIVE DETERMINATION OF D-DIMER
Registration Information
Analysis ID
1403R2021 SSA
Registration Date
September 13, 2021
Manufacturer / Fabricante
Name (English)
KABLACOMERCIAL,S.A.DE C.V.