Mexico COFEPRIS registration 1076R2019 SSA

QUANTA FLASH® M2 (MIT3) CALIBRATORS

EN: QUANTA FLASH® M2 (MIT3) CALIBRATORS
Mexico flagMexico·Clase I·III. DIAGNOSTIC AGENTS·I.L. DIAGNOSTICS, S.A. DE C.V.·Registered May 20, 2019
Product Use / Uso del Producto
Spanish

LOS QUANTA FLASH M2 (MIT3) CALIBRATORS ESTÁN DESTINADOS A UTILIZARSE CON EL INMUNOENSAYO POR QUIMIOLUMINISCENCIA QUANTA FLASH M2 (MIT3) PARA LA DETERMINACIÓN DE ANTICUERPOS IGG ANTIMITOCONDRIALES EN SUERO HUMANO. CADA CALIBRADOR ESTABLECE UN PUNTO DE REFE

English

QUANTA FLASH M2 (MIT3) CALIBRATORS ARE INTENDED FOR USE WITH THE QUANTA FLASH M2 (MIT3) CHEMOLUMINESCENCE IMMUNOASSAY FOR THE DETERMINATION OF ANTIMITOCHONDRIAL IGG ANTIBODIES IN HUMAN SERUM. EACH CALIBRATOR ESTABLISHES A REFERENCE POINT

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 CALIBRADOR
Trade Name (English)
CALIBRATOR REAGENT
Registration information
Analysis ID
1076R2019 SSA
Registration Date
May 20, 2019
Manufacturer / Fabricante
Name (English)
I.L. DIAGNOSTICS, S.A. DE C.V.
About this record

Access comprehensive regulatory information for QUANTA FLASH® M2 (MIT3) CALIBRATORS (QUANTA FLASH® M2 (MIT3) CALIBRATORS) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1076R2019 SSA and manufactured by I.L. DIAGNOSTICS, S.A. DE C.V.. The device was registered on May 20, 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.

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