Pure Global

M-PIMA™ HIV-1/2 VL - COFEPRIS Registration 658R2022 SSA

Access comprehensive regulatory information for M-PIMA™ HIV-1/2 VL (M-PIMA™ HIV-1/2 VL) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 658R2022 SSA and manufactured by ABBOTTLABORATORIES DEMÉXICO, S.A. DE C.V.. The device was registered on July 22, 2022.

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.

Free Database
Powered by Pure Global AI
COFEPRIS Official Data
Clase II
658R2022 SSA
M-PIMA™ HIV-1/2 VL
COFEPRIS Analysis ID: 658R2022 SSA
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Use / Uso del Producto
Spanish

M-PIMA™ HIV-1/2 VL ES UN TEST CUANTITATIVO DEAMPLIFICACIÓN DE ÁCIDO NUCLEICO, PARA LACUANTIFICACIÓN DEL ARN DEL VIRUS DEINMUNODEFICIENCIA HUMANA (VIH) TIPO 1 GRUPOS M/N Y O, Y VIH TIPO 2 EN MUESTRAS DE PLASMA HUMANAS DEINDIVIDUOSCONDIAGNÓSTICODEINFECCIÓNPORVIH-1OVIH-2, UTILIZANDO EL M-PIMA™ ANALYSER PARA ELPROCESAMIENTO DE MUESTRAS, AMPLIFICACIÓN YDETECCIÓN DE FORMA AUTOMÁTICA. PARA USO ENLABORATORIO Y ENTORNOS EXTERNOS. AGENTE DEDIAGNÓSTICO PARA USO IN VITRO. PARA USO EXCLUSIVO

English

M-PIMA HIV-1/2 VL IS A QUANTITATIVE NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTIFICATION OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) TYPE 1 GROUPS M/N AND O, AND HIV TYPE 2 RNA IN HUMAN PLASMA SAMPLES FROM INDIVIDUALS DIAGNOSED WITH HIV-1OVIH-2 INFECTION, USING THE M-PIMA™™ ANALYSER FOR AUTOMATIC SAMPLE PROCESSING, AMPLIFICATION AND DETECTION. FOR USE IN LABORATORY AND OUTDOOR ENVIRONMENTS. DIAGNOSTIC AGENT FOR IN VITRO USE. FOR USE ONLY

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
III. AGENTES DEDIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
CARTUCHOSPARAMONITOREODE LA CARGA VIRAL DE VIH-1/2
Trade Name (English)
CARTRIDGES FOR HIV-1/2 VIRAL LOAD MONITORING
Registration Information
Analysis ID
658R2022 SSA
Registration Date
July 22, 2022
Manufacturer / Fabricante
Name (English)
ABBOTTLABORATORIES DE MÉXICO, S.A. DE C.V.