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NOVA LITE® DAPI ANCA (FORMALIN) KIT - COFEPRIS Registration 2100R2019 SSA

Access comprehensive regulatory information for NOVA LITE® DAPI ANCA (FORMALIN) KIT (NOVA LITE® DAPI ANCA (FORMALIN) KIT) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 2100R2019 SSA and manufactured by I.L. DIAGNOSTICS, S.A. DE C.V.. The device was registered on November 07, 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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COFEPRIS Official Data
Clase I
2100R2019 SSA
NOVA LITE® DAPI ANCA (FORMALIN) KIT
COFEPRIS Analysis ID: 2100R2019 SSA
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Product Use / Uso del Producto
Spanish

EL NOVA LITE DAPI ANCA (FORMALIN) KIT ES UN ENSAYO DE INMUNOFLUORESCENCIA INDIRECTA PARA LA DETECCIÓN CUALITATIVA Y LA DETERMINACIÓN SEMICUANTITATIVA DE ANTICUERPOS ANTI-CITOPLASMA DE NEUTRÓFILO (ANCA) DE ISOTIPOS IGG EN SUERO HUMANO MEDIANTE UN MICROSCOP

English

THE NOVA LITE DAPI ANCA (FORMALIN) KIT IS AN INDIRECT IMMUNOFLUORESCENCE ASSAY FOR THE QUALITATIVE DETECTION AND SEMI-QUANTITATIVE DETERMINATION OF ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA) OF IGG ISOTYPES IN HUMAN SERUM BY MICROSCOPIC

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 PARA LA DETERMINACIÓN DE ANTICUERPOS ANTI-CITOPLASMA DE NEUTRÓFILO.
Trade Name (English)
REAGENT FOR THE DETERMINATION OF ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODIES.
Registration Information
Analysis ID
2100R2019 SSA
Registration Date
November 07, 2019
Manufacturer / Fabricante
Name (English)
I.L. DIAGNOSTICS, S.A. DE C.V.