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NOVALITE®DAPIANCA(ETHANOL)KIT - COFEPRIS Registration 72R2020 SSA

Access comprehensive regulatory information for NOVALITE®DAPIANCA(ETHANOL)KIT (NOVALITE®DAPIANCA(ETHANOL)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 72R2020 SSA and manufactured by I.L. DIAGNOSTICS, S.A. DE C.V.. The device was registered on February 05, 2020.

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
72R2020 SSA
NOVALITE®DAPIANCA(ETHANOL)KIT
COFEPRIS Analysis ID: 72R2020 SSA
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Product Use / Uso del Producto
Spanish

ELNOVALITEDAPIANCA(ETHANOL)KITESUNENSAYO DE INMUNOFLUORESCENCIAINDIRECTAPARALADETECCIÓNCUALITATIVAYLA DETERMINACIÓN SEMICUANTITATIVA DEANTICUERPOS ANTI-CITOPLASMA DENEUTRÓFILO (ANCA) DE ISOTIPOS IGG ENSUEROHUMANOMEDIANTEUNMICROSCOPIODE FLUORESCENCIA MANUAL O ELMICROSCOPIO DE FLUORESCENCIAAUTOMÁTICO NOVA VIEW. LA PRESENCIA DEANCA, JUNTO CON OTRAS PRUEBASSEROLÓGICAS,RADIOLÓGICASEHISTOLÓGICASY LOS RESULTADOS CLÍNICOS, AYUDA EN ELDIAGNÓSTICO DE LAS VASCULITIS ASOCIAD

English

ELNOVALITEDAPIANCA(ETHANOL)KITESAN INDIRECT IMMUNOFLUORESCENCE ASSAY FOR THE QUALITATIVE DETECTION AND SEMI-QUANTITATIVE DETERMINATION OF ANTIBODIES TO ANTI-NEUTROPHIL CYTOPLASM (ANCA) OF IGG ISOTYPES IN HUMAN SERUM BY MEANS OF A MANUAL FLUORESCENCE MICROSCOPE OR THE NOVA VIEW AUTOMATIC FLUORESCENCE MICROSCOPE. THE PRESENCE OF ANCA, TOGETHER WITH OTHER SEROLOGICAL, RADIOLOGICAL AND HISTOLOGICAL TESTS AND CLINICAL RESULTS, HELPS IN THE DIAGNOSIS OF ASSOCIATED VASCULITIS.

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)
REACTIVOPARALADETERMINACIÓNDEANTICUERPOSANTI-CITOPLASMADENEUTRÓFILO(ANCA)DEISOTIPOSIGG.
Trade Name (English)
REACTIVOPARALADETERMINACIÓNDEANTICUERPOSANTI-CITOPLASMDENEUTRÓFILO(ANCA)DEISOTIPOSIGG.
Registration Information
Analysis ID
72R2020 SSA
Registration Date
February 05, 2020
Manufacturer / Fabricante
Name (English)
I.L. DIAGNOSTICS, S.A. DE C.V.