ANTINUCLEAR ANTIBODY (ANA) - ANVISA Registration 10300390680
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 10300390680 and manufactured by ORGENTEC DIAGNOSTIKA GMBH. The registration is held by VYTTRA DIAGNOSTICOS S.A. 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., DIA.PRO DIAGNOSTIC BIOPROBES SRL, 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
10300390680
25351250778201927
00904728000148
Company Information
Dates and Status
May 20, 2019
VIGENTE
09/18/2025 19:00:01
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
Anti-Nucleosomas ELISA (IgG)
EUROIMMUN AG
10338930048
Mar 24, 2008
ANTINUCLEAR ANTIBODY (ANA)
ANTI HISTONA
ORGENTEC DIAGNOSTIKA GMBH
10300390782
Jul 08, 2019
ANTINUCLEAR ANTIBODY (ANA)
FamÃlia MAGLUMI Antinucleossomos para IgG (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
80102513500
Aug 11, 2025
ANTINUCLEAR ANTIBODY (ANA)
IgG anti dsDNA
DIA.PRO DIAGNOSTIC BIOPROBES SRL
82532910012
Jan 02, 2023
ANTINUCLEAR ANTIBODY (ANA)
IgG anti dsDNA
DIA.PRO DIAGNOSTIC BIOPROBES SRL
81905510010
Feb 11, 2021
INOVA DIAGNOSTICS, INC.• United States of America
DIA.PRO DIAGNOSTIC BIOPROBES SRL• Italy
ORGENTEC DIAGNOSTIKA GMBH• Germany
PHADIA AB• Sweden
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.• China
ANTICORPO ANTINUCLEAR (ANA)
FamÃlia 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)
FamÃlia MAGLUMI® Triagem de ANA (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790431
Sep 16, 2024
ANTICORPO ANTINUCLEAR (ANA)
FamÃlia MAGLUMI® IgG anti-Scl-70 (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790433
Sep 16, 2024
ANTICORPO ANTINUCLEAR (ANA)
FamÃlia MAGLUMI® IgG anti-dsDNA (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790436
Sep 16, 2024