Pure Global

A1CD - COFEPRIS Registration 1343R2019 SSA

Access comprehensive regulatory information for A1CD (A1CD) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1343R2019 SSA and manufactured by PRODUCTOS ROCHE, S.A. DE C.V.. The device was registered on July 16, 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.

Free Database
Powered by Pure Global AI
COFEPRIS Official Data
Clase I
1343R2019 SSA
A1CD
COFEPRIS Analysis ID: 1343R2019 SSA
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Use / Uso del Producto
Spanish

EL REACTIVO HEMOLIZANTE SE USA EN LOS SISTEMAS ROCHE PARA DILUIR EL TEST TINA-QUANT HEMOGLOBIN A1C GEN 3. AGENTE DE DIAGNร“STICO PARA USO IN VITRO. PARA USO EXCLUSIVO EN LABORATORIOS CLรNICOS O DE GABINETES.

English

THE HEMOLYSING REAGENT IS USED IN ROCHE SYSTEMS TO DILUTE THE TINA-QUANT HEMOGLOBIN A1C GEN 3 TEST. DIAGNOSTIC AGENT FOR IN VITRO USE. FOR USE IN CLINICAL OR CABINET LABORATORIES ONLY.

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DE DIAGNร“STICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
REACTIVO HEMOLIZANTE
Trade Name (English)
HEMOLIZING REAGENT
Registration Information
Analysis ID
1343R2019 SSA
Registration Date
July 16, 2019
Manufacturer / Fabricante
Name (English)
PRODUCTOS ROCHE, S.A. DE C.V.