Mexico COFEPRIS registration 1010R2021 SSA

CERTUM HBSAG RAPID TESTCASSETTE (WHOLEBLOOD/SERUM/PLASMA)

EN: CERTUM HBSAG RAPID TESTCASSETTE (WHOLEBLOOD/SERUM/PLASMA)
Mexico flagMexico·Clase II·III. DIAGNOSTIC AGENTS·KABLACOMERCIAL,S.A.DE C.V.·Registered June 16, 2021
Product Use / Uso del Producto
Spanish

LA PRUEBA CERTUM HBSAG RAPID TESTCASSETTE (WHOLE BLOOD/SERUM/PLASMA)ES UN INMUNOENSAYO CROMATOGRÁFICORÁPIDO PARA LA DETECCIÓN CUALITATIVADEL ANTÍGENO DE SUPERFICIE DE LAHEPATITIS B EN SANGRE TOTAL, SUERO OPLASMA.

English

THE CERTUM HBSAG RAPID TESTCASSETTE (WHOLE BLOOD/SERUM/PLASMA) TEST IS A RAPID CHROMATOGRAPHIC IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN IN WHOLE BLOOD, SERUM OR PLASMA.

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)
KIT DE DIAGNÓSTICO IN VITRO PARAANTICUERPOS TOTALES ANTI-SUPERFICIEDEL VHB MEDIANTE PRUEBA RÁPIDA
Trade Name (English)
IN VITRO DIAGNOSTIC KIT FOR TOTAL ANTI-SURFACE ANTIBODIES OF HBV BY RAPID TEST
Registration information
Analysis ID
1010R2021 SSA
Registration Date
June 16, 2021
Manufacturer / Fabricante
Name (English)
KABLACOMERCIAL,S.A.DE C.V.
About this record

Access comprehensive regulatory information for CERTUM HBSAG RAPID TESTCASSETTE (WHOLEBLOOD/SERUM/PLASMA) (CERTUM HBSAG RAPID TESTCASSETTE (WHOLEBLOOD/SERUM/PLASMA)) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1010R2021 SSA and manufactured by KABLACOMERCIAL,S.A.DE C.V.. The device was registered on June 16, 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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