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MAGLUMI CONTROL DEINMUNOENSAYO - COFEPRIS Registration 1346R2021 SSA

Access comprehensive regulatory information for MAGLUMI CONTROL DEINMUNOENSAYO (MAGLUMI CONTROL DEINMUNOENSAYO) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1346R2021 SSA and manufactured by ISA HEALTH S.A. DE C.V.. The device was registered on June 09, 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
1346R2021 SSA
MAGLUMI CONTROL DEINMUNOENSAYO
COFEPRIS Analysis ID: 1346R2021 SSA
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Product Use / Uso del Producto
Spanish

PARA REALIZAR PROCEDIMIENTOS DECONTROL DE CALIDAD CON LOS KITS DEREACTIVOS DE INMUNOENSAYO (CLIA)MAGLUMI, CUANDO ES UTILIZADA PARA LADETERMINACIÓN CUANTITATIVA DE T3., T4,FT3,FT4,TSH,FSH,LH,PRL,PRG,,ESTRADIOL,TESTOSTERONA, HCG/Β-HCG, INSULINAINSULINAYPÉPTIDOCENSUEROHUMANOPARASU USOEN DIAGNÓSTICOIN VITROYEXCLUSIVO DE LABORATORIOS CLÍNICOS ODE GABINETES.

English

TO PERFORM QUALITY CONTROL PROCEDURES WITH IMMUNOASSAY REAGENT KITS (CLIA) MAGLUMI, WHEN USED FOR THE QUANTITATIVE DETERMINATION OF T3., T4,FT3,FT4,TSH,FSH,LH,PRL,PRG,,ESTRADIOL,TESTOSTERONE, HCG / Β-HCG, INSULININSULIN AND HUMAN SERUM PEPTIDE FOR USE IN VITROY DIAGNOSIS EXCLUSIVE CLINICAL LABORATORIES OR CABINETS.

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)
REACTIVO CONTROL DE DIAGNÓSTICO INVITRO PARA INMUNOLOGÍA
Trade Name (English)
INVITRO DIAGNOSTIC CONTROL REAGENT FOR IMMUNOLOGY
Registration Information
Analysis ID
1346R2021 SSA
Registration Date
June 09, 2021
Manufacturer / Fabricante
Name (English)
ISA HEALTH S.A. DE C.V.