Mexico COFEPRIS registration 1885R2019 SSA

CERTUM AFP RAPID TEST CASSETTE (WHOLE BLOOD/ SERUM/PLASMA)

EN: CERTUM AFP RAPID TEST CASSETTE (WHOLE BLOOD/ SERUM/PLASMA)
Mexico flagMexico·Clase I·III. DIAGNOSTIC AGENTS·KABLA COMERCIAL, S.A. DE C.V.·Registered September 19, 2019
Product Use / Uso del Producto
Spanish

INMUNOENSAYO CROMATOGRÁFICO RÁPIDO PARA LA DETECCIÓN CUALITATIVA DE LA AFP EN LA SANGRE TOTAL, SUERO O PLASMA PARA AYUDAR EN EL DIAGNÓSTICO DE CARCINOMA HEPATOCELULAR O DEFECTOS DEL TUBO NEURAL DEL FETO.

English

RAPID CHROMATOGRAPHIC IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF AFP IN WHOLE BLOOD, SERUM, OR PLASMA TO AID IN THE DIAGNOSIS OF HEPATOCELLULAR CARCINOMA OR NEURAL TUBE DEFECTS OF THE FETUS.

Device classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
PRUEBA RÁPIDA PARA LA DETECCIÓN DE ALFAFETOPROTEÍNA (AFP)
Trade Name (English)
RAPID ALPHA-FETOPROTEIN (AFP) TEST
Registration information
Analysis ID
1885R2019 SSA
Registration Date
September 19, 2019
Manufacturer / Fabricante
Name (English)
KABLA COMERCIAL, S.A. DE C.V.
About this record

Access comprehensive regulatory information for CERTUM AFP RAPID TEST CASSETTE (WHOLE BLOOD/ SERUM/PLASMA) (CERTUM AFP RAPID TEST CASSETTE (WHOLE BLOOD/ SERUM/PLASMA)) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1885R2019 SSA and manufactured by KABLA COMERCIAL, S.A. DE C.V.. The device was registered on September 19, 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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