Mexico COFEPRIS registration 241R2019 SSA

ATELLICA™ IM HIV AG/AB COMBO (CHIV)

EN: ATELLICA™ IM HIV AG/AB COMBO (CHIV)
Mexico flagMexico·Clase II·III. DIAGNOSTIC AGENTS·SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L DE C.V.·Registered February 11, 2019
Product Use / Uso del Producto
Spanish

EL ENSAYO ATELLICA™ IM HIV AG/AB COMBO (CHIV) ESTÁ PREVISTO PARA EL USO DIAGNÓSTICO IN VITRO EN LA DETECCIÓN CUALITATIVA SIMULTÁNEA DEL ANTÍGENO P24 DEL VIRUS DE INMUNODEFICIENCIA HUMANA Y LOS ANTICUERPOS CONTRA LOS VIRUS DE INMUNODEFICIENCIA HUMANA TIPO

English

THE ATELLICA™ IM HIV AG/AB COMBO (CHIV) ASSAY IS INTENDED FOR IN VITRO DIAGNOSTIC USE IN THE SIMULTANEOUS QUALITATIVE DETECTION OF HUMAN IMMUNODEFICIENCY VIRUS P24 ANTIGEN AND ANTIBODIES TO HUMAN IMMUNODEFICIENCY VIRUS TYPE

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)
ENSAYO PARA LA DETERMINACIÓN DE VIH
Trade Name (English)
HIV ASSAY
Registration information
Analysis ID
241R2019 SSA
Registration Date
February 11, 2019
Manufacturer / Fabricante
Name (English)
SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L DE C.V.
About this record

Access comprehensive regulatory information for ATELLICA™ IM HIV AG/AB COMBO (CHIV) (ATELLICA™ IM HIV AG/AB COMBO (CHIV)) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 241R2019 SSA and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L DE C.V.. The device was registered on February 11, 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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