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GRUPO DE BILIRRUBINAS ERBA - COFEPRIS Registration 676R2021 SSA

Access comprehensive regulatory information for GRUPO DE BILIRRUBINAS ERBA (ERBA BILIRUBIN GROUP) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 676R2021 SSA and manufactured by HRD HIGHRESOLUTION DIAGNOSTICS, S.A. DEC.V.. The device was registered on April 19, 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 I
676R2021 SSA
GRUPO DE BILIRRUBINAS ERBA
COFEPRIS Analysis ID: 676R2021 SSA
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Product Use / Uso del Producto
Spanish

LOS REACTIVOS GRUPO DE BILIRRUBINASERBA ESTÁN DESTINADOS AL DIAGNÓSTICOIN VITRO PARA LA DETERMINACIÓNCUANTITATIVA DE BILIRRUBINA TOTAL YDIRECTA, EMPLEANDO LOS EQUIPOS DEQUÍMICA CLÍNICA MARCA ERBA Y ERBA XL.PARAUSODEDIAGNÓSTICOINVITRO.PARAUSOEXCLUSIVODELABORATORIOSCLÍNICOSO DE GABINETE.

English

THE REAGENTS GROUP OF BILIRUBINASERBA ARE INTENDED FOR IN VITRO DIAGNOSIS FOR THE QUANTITATIVE DETERMINATION OF TOTAL AND DIRECT BILIRUBIN, USING THE EQUIPMENT DEQUÍMICA CLÍNICA BRAND ERBA AND ERBA XL.PARA USO DEDIAGNÓSTICOINVITRO. FOR EXCLUSIVE USE OF CLINICAL LABORATORIES OR CABINET.

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
REACTIVOS DE DIAGNÓSTICO IN VITROPARA BILLIRUBINA DIRECTA Y TOTAL
Trade Name (English)
IN VITRO DIAGNOSTIC REAGENTS FOR DIRECT AND TOTAL BILLIRUBIN
Registration Information
Analysis ID
676R2021 SSA
Registration Date
April 19, 2021
Manufacturer / Fabricante
Name (English)
HRD HIGHRESOLUTION DIAGNOSTICS, S.A. DEC.V.