NOVA LITE® DAPI ANA KIT - COFEPRIS Registration 71R2020 SSA
Access comprehensive regulatory information for NOVA LITE® DAPI ANA KIT (NOVA LITE® DAPI ANA 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 71R2020 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.
ELKITNOVALITEDAPIANAESUNENSAYODEINMUNOFLUORESCENCIA INDIRECTA PARA LADETECCIÓNCUALITATIVAYLADETERMINACIÓNSEMICUANTITATIVA DE ANTICUERPOSANTINUCLEARES DEL ISOTIPO IGG EN SUEROHUMANO MEDIANTE UN MICROSCOPIO DEFLUORESCENCIA MANUALO ELMICROSCOPIODE FLUORESCENCIA AUTOMÁTICO NOVAVIEW®. LA PRESENCIA DE ANTICUERPOSANTINUCLEARES PUEDE UTILIZARSE JUNTO CON OTRAS PRUEBAS SEROLÓGICAS Y LOSRESULTADOS CLÍNICOS PARA AYUDAR ADIAGNOSTICAR EL LUPUS ERITEMATOSOSISTÉMICO Y OTRAS ENFERMEDA
ELKITNOVALITEDAPIANA IS AN INDIRECT IMMUNOFLUORESCENCE ASSAY FOR THE QUALITATIVE DETECTION AND SEMIQUANTITATIVE DETERMINATION OF ANTINUCLEAR ANTIBODIES OF THE IGG ISOTYPE IN HUMAN SERUM USING A MANUAL FLUORESCENCE MICROSCOPE OR THE NOVAVIEW® AUTOMATIC FLUORESCENCE MICROSCOPE. THE PRESENCE OF ANTINUCLEAR ANTIBODIES MAY BE USED IN CONJUNCTION WITH OTHER SEROLOGICAL TESTS AND CLINICAL OUTCOMES TO HELP DIAGNOSE SYSTEMIC LUPUS ERYTHEMATOSUS AND OTHER DISEASES.