ANTINUCLEAR ANTIBODY (ANA) - ANVISA Registration 10303460442
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 10303460442 and manufactured by HUMAN GMBH. The registration is held by IN VITRO DIAGNOSTICA 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
10303460442
25351070038201246
42837716000198
Company Information
Dates and Status
Apr 02, 2012
VIGENTE
09/18/2025 19:00:01
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
ANTINUCLEAR ANTIBODY (ANA)
ANAscreen
GENERIC ASSAYS GA
80464810746
Dec 17, 2020
ANTINUCLEAR ANTIBODY (ANA)
AUTO-SCREEN (TRIAGEM AUTOIMUNE) IMUNOFLUORESCENCIA
SCIMEDX CORPORATION
10225960025
Jun 13, 2001
ANTINUCLEAR ANTIBODY (ANA)
ENAscreen
ORGENTEC DIAGNOSTIKA GMBH
80416660113
Jan 09, 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