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ARCHITECT ANTI-HCV - COFEPRIS Registration 2221R2021 SSA

Access comprehensive regulatory information for ARCHITECT ANTI-HCV (ARCHITECT ANTI-HCV) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 2221R2021 SSA and manufactured by ABBOTT LABORATORIES DEMÉXICO, S.A. DE C.V.. The device was registered on December 27, 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
2221R2021 SSA
ARCHITECT ANTI-HCV
COFEPRIS Analysis ID: 2221R2021 SSA
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Product Use / Uso del Producto
Spanish

EL ENSAYO ARCHITECT ANTI-HCV ES UNINMUNOANÁLISIS QUIMIOLUMINISCENTE DEMICROPARTÍCULAS (CMIA) PARA LADETECCIÓN CUALITATIVA DE ANTICUERPOSFRENTEALVIRUSDELAHEPATITISC(ANTI-VHC) EN SUERO Y PLASMA HUMANOS,INCLUYENDO ESPECÍMENES RECOGIDOSPOST MORTEM (SIN LATIDO CARDÍACO).AGENTE DE DIAGNÓSTICO IN VITRO. PARAUSO EXCLUSIVO DE LABORATORIOS DEANÁLISIS CLÍNICOS O DE GABINETE.

English

THE ARCHITECT ANTI-HCV ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUALITATIVE DETECTION OF ANTIBODIES TO HEPATITIS VIRUS (ANTI-HCV) IN HUMAN SERUM AND PLASMA, INCLUDING SPECIMENS COLLECTED POSTMORTEM (WITHOUT HEARTBEAT). IN VITRO DIAGNOSTIC AGENT. FOR THE EXCLUSIVE USE OF CLINICAL ANALYSIS LABORATORIES OR CABINET.

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)
ENSAYOPARALADETECCIÓNCUALITATIVADEANTICUERPOSFRENTEALVIRUSDELAHEPATITIS C
Trade Name (English)
ENSAYOPARALADETECCIÓNCUALITATIVADEANTICUERPOSFRENTEALVIRUSDELAHEPATITIS C
Registration Information
Analysis ID
2221R2021 SSA
Registration Date
December 27, 2021
Manufacturer / Fabricante
Name (English)
ABBOTT LABORATORIES DEMÉXICO, S.A. DE C.V.