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CERTUM AFP RAPID TEST CASSETTE (WHOLE BLOOD/ SERUM/PLASMA) - COFEPRIS Registration 1885R2019 SSA

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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COFEPRIS Official Data
Clase I
1885R2019 SSA
CERTUM AFP RAPID TEST CASSETTE (WHOLE BLOOD/ SERUM/PLASMA)
COFEPRIS Analysis ID: 1885R2019 SSA
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Product Use / Uso del Producto
Spanish

INMUNOENSAYO CROMATOGRรFICO RรPIDO PARA LA DETECCIร“N CUALITATIVA DE LA AFP EN LA SANGRE TOTAL, SUERO O PLASMA PARA AYUDAR EN EL DIAGNร“STICO 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 DIAGNร“STICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
PRUEBA RรPIDA PARA LA DETECCIร“N DE ALFAFETOPROTEรNA (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.