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COBAS® MPX TEST - COFEPRIS Registration 1061R2021 SSA

Access comprehensive regulatory information for COBAS® MPX TEST (COBAS® MPX TEST) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1061R2021 SSA and manufactured by PRODUCTOS ROCHE,S.A. DE C.V.. The device was registered on June 30, 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
1061R2021 SSA
COBAS® MPX TEST
COFEPRIS Analysis ID: 1061R2021 SSA
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Product Use / Uso del Producto
Spanish

LAPRUEBACOBAS®MPX,PARAUSOENLOSCOBAS®6800YLOSCOBAS®8800SYSTEMS,ESUNAPRUEBACUALITATIVAINVITROPARALADETECCIÓNDIRECTADELARNDELGRUPOM DEL VIRUS DE INMUNODEFICIENCIAHUMANO TIPO 1(VIH-1), ARN DEL GRUPO ODELVIRUSDEINMUNODEFICIENCIAHUMANOTIPO 1, ARN DEL VIRUS DEINMUNODEFICIENCIAHUMANOTIPO2(VIH-2),ARNDELVIRUSDELAHEPATITISC(VHC)YELADNDELVIRUSDELAHEPATITISB(VHB)ENPLASMAY SUERO HUMANOS. ESTAPRUEBASE HA DISEÑADO COMO CRIBADO DEMUESTRAS DE DONAN

English

THE COBAS MPX TEST,FOR USE IN THE COBAS®6800AND THE COBAS®®8800SYSTEMS,IS A QUALITATIVE TESTINVITROPARALADEDIRECT DETECTION OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1(HIV-1) MGROUPM, HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 RNA, HUMAN IMMUNODEFICIENCY VIRUS TYPE 2(HIV-2) RNA, HEPATITIS VIRUS RNA(HCV)AND HEPATITISB(HBV) MNA IN HUMAN PLASMA AND SERUM. THIS TEST IS DESIGNED TO SCREEN DONAN SAMPLES

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)
PRUEBA PARA DETERMINACIÓNCUALITATIVA POR PCR DEL ARN DE VIH,VHC Y ADN DE VHB
Trade Name (English)
TEST FOR QUALITATIVE DETERMINATION BY PCR OF HIV RNA, HCV AND HBV DNA
Registration Information
Analysis ID
1061R2021 SSA
Registration Date
June 30, 2021
Manufacturer / Fabricante
Name (English)
PRODUCTOS ROCHE,S.A. DE C.V.