ANTINUCLEAR ANTIBODY (ANA) - ANVISA Registration 10300390646
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 10300390646 and manufactured by IMMUNO CONCEPTS N.A.,LTD.. 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., 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
10300390646
25351250652201952
00904728000148
Company Information
Dates and Status
May 20, 2019
VIGENTE
09/18/2025 19:00:01
ANTINUCLEAR ANTIBODY (ANA)
FLUORESCENT NDNA
IMMUNO CONCEPTS N.A.,LTD.
10300390644
May 20, 2019
ANTINUCLEAR ANTIBODY (ANA)
nDNA IFA plus
GA GENERIC ASSAYS GMBH
80836930097
Jul 22, 2021
ANTINUCLEAR ANTIBODY (ANA)
ANTI-DNA ENZIMAIMUNOENSAIO
HEMAGEN DIAGNOSTICS, INC.
10322610028
Apr 08, 2019
ANTINUCLEAR ANTIBODY (ANA)
Immuglo anti-nDNA Antibody IFA Kit
IMMCO DIAGNOSTICS, INC.
80944340031
Apr 15, 2019
ANTINUCLEAR ANTIBODY (ANA)
Anticorpos Anti-nDNA (nDNA)
ORGENTEC DIAGNOSTIKA GMBH
10300390824
Jul 08, 2019
INOVA DIAGNOSTICS, INC.• United States of America
ORGENTEC DIAGNOSTIKA GMBH• Germany
DIA.PRO DIAGNOSTIC BIOPROBES SRL• Italy
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