ANTINUCLEAR ANTIBODY (ANA) - ANVISA Registration 80464810892
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 80464810892 and manufactured by GA GENERIC ASSAYS GMBH. The registration is held by ARGOSLAB DISTRIBUIDORA DE PRODUTOS PARA LABORATÓRIOS 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.

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Registration Details
80464810892
25351017054202431
09377976000152
Company Information
Dates and Status
Feb 26, 2024
VIGENTE
09/18/2025 19:00:01
ANTINUCLEAR ANTIBODY (ANA)
NUCLEO-9-LINE
ORGENTEC DIAGNOSTIKA GMBH
10300390648
May 20, 2019
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
ANA-9-LINE
ORGENTEC DIAGNOSTIKA GMBH
10300390599
May 20, 2019
ANTINUCLEAR ANTIBODY (ANA)
EUROLINE: Miopatias Inflamatórias Autoimunes 16 Ag (IgG)
EUROIMMUN AG
10338930219
Apr 08, 2019
ANTINUCLEAR ANTIBODY (ANA)
ANA SCREEN
ORGENTEC DIAGNOSTIKA GMBH
10300390708
May 20, 2019
ANTINUCLEAR ANTIBODY (ANA)
ANA Screen
DIAMETRA S.R.L.
80345000299
Oct 21, 2019
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