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SARS-COV-2 EXTRACTIONSOLUTIONS ROCHE - COFEPRIS Registration 1958R2021 SSA

Access comprehensive regulatory information for SARS-COV-2 EXTRACTIONSOLUTIONS ROCHE (SARS-COV-2 EXTRACTIONSOLUTIONS ROCHE) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1958R2021 SSA and manufactured by PRODUCTOS ROCHE,S.A. DE C.V.. The device was registered on November 24, 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
1958R2021 SSA
SARS-COV-2 EXTRACTIONSOLUTIONS ROCHE
COFEPRIS Analysis ID: 1958R2021 SSA
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Product Use / Uso del Producto
Spanish

LAS SOLUCIÓNES DE EXTRACCIÓNSARS‑COV‑2 ESTÁNDESTINADAS ALAELUCIÓN, LAREDUCCIÓNDELACARGAVIRALYELTRANSPORTEDELASMUESTRAS UTILIZADAS CON EL ENSAYOELECSYSSARS‑COV‑2 ANTIGEN.AGENTE DE DIAGNÓSTICO PARA USO INVITRO. PARA USO EXCLUSIVO DELABORATORIOS CLÍNICOS O DE GABINETES

English

SARS-COV-2 EXTRACTION SOLUTIONS ARE INTENDED FOR ELUTION, VIRAL LOAD REDUCTION AND TRANSPORT OF SAMPLES USED WITH THE ELECSYSSARS-COV-2 ANTIGEN ASSAY. DIAGNOSTIC AGENT FOR INVITRO USE. FOR USE ONLY IN CLINICAL LABORATORIES OR CABINETS

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)
SOLUCIÓN DE EXTRACCIÓN
Trade Name (English)
EXTRACTION SOLUTION
Registration Information
Analysis ID
1958R2021 SSA
Registration Date
November 24, 2021
Manufacturer / Fabricante
Name (English)
PRODUCTOS ROCHE,S.A. DE C.V.