ANTINUCLEAR ANTIBODY (ANA) - ANVISA Registration 80406120013
Access comprehensive regulatory information for ANTINUCLEAR ANTIBODY (ANA) in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 80406120013 and manufactured by BIO GENETIX SRL. The registration is held by BYOBRASIL COMÉRCIO DE EQUIPAMENTOS MÉDICO HOSPITALARES E SEUS INSUMOS LTDA with validity until currently active (VIGENTE).
This page provides complete technical specifications for this device, regulatory compliance details, 5 similar products found using AI-powered semantic search, 5 companies making the same product including INOVA DIAGNOSTICS, INC., ORGENTEC DIAGNOSTIKA GMBH, and 5 recent registrations in the same technical category. Pure Global AI offers free access to over 100,000+ Brazilian medical device registrations, helping global MedTech companies navigate ANVISA regulations, identify competitors, and discover partnership opportunities efficiently.

Janaina dos Santos de Miranda
🇧🇷 Brazil Regulatory Expert
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Registration Details
80406120013
25351314392201097
08317750000101
Company Information
Dates and Status
Nov 22, 2010
VIGENTE
09/18/2025 19:00:01
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
ENA Screening IgG
DIA.PRO DIAGNOSTIC BIOPROBES SRL
81905510009
Feb 11, 2021
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
ENA Screening IgG
DIA.PRO DIAGNOSTIC BIOPROBES SRL
82532910009
Jan 02, 2023
ANTINUCLEAR ANTIBODY (ANA)
ENAscreen
ORGENTEC DIAGNOSTIKA GMBH
80416660113
Jan 09, 2023
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
ANTI-nDNA IgG IMUNOFLUORESCENCIA
HEMAGEN DIAGNÓSTICS
10322610027
Apr 08, 2019
ANTINUCLEAR ANTIBODY (ANA)
ANA Screening IgG
DIA.PRO DIAGNOSTIC BIOPROBES SRL
82532910010
Jan 02, 2023
ANTICORPO ANTINUCLEAR (ANA)
Família MAGLUMI Antinucleossomos para IgG (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
80102513500
Aug 11, 2025
ANTICORPO ANTINUCLEAR (ANA)
AESKUSLIDES ANA HEp-2
AESKU DIAGNOSTICS GMBH & CO. KG
82910510002
Apr 07, 2025
ANTICORPO ANTINUCLEAR (ANA)
Família MAGLUMI® Triagem de ANA (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790431
Sep 16, 2024
ANTICORPO ANTINUCLEAR (ANA)
Família MAGLUMI® IgG anti-Scl-70 (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790433
Sep 16, 2024
ANTICORPO ANTINUCLEAR (ANA)
Família MAGLUMI® IgG anti-dsDNA (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790436
Sep 16, 2024