Mexico COFEPRIS registration 1077R2019 SSA

QUANTA FLASH® M2 (MIT3) CONTROLS

EN: QUANTA FLASH® M2 (MIT3) CONTROLS
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) CONTROLS ESTÁN DESTINADOS A UTILIZARSE CON EL INMUNOENSAYO POR QUIMIOLUMINISCENCIA QUANTA FLASH® M2 (MIT3) PARA EL CONTROL DE LA CALIDAD EN LA DETERMINACIÓN DE ANTICUERPOS IGG ANTIMITOCONDRIALES EN SUERO HUMANO

English

QUANTA FLASH® M2 (MIT3) CONTROLS ARE INTENDED FOR USE WITH THE QUANTA FLASH® M2 (MIT3) CHEMOLUMINESCENCE IMMUNOASSAY FOR QUALITY CONTROL IN THE DETERMINATION OF ANTIMITOCHONDRIAL IGG ANTIBODIES IN HUMAN SERUM

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
Trade Name (English)
REACTIVE CONTROL
Registration information
Analysis ID
1077R2019 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) CONTROLS (QUANTA FLASH® M2 (MIT3) CONTROLS) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1077R2019 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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