ANTINUCLEAR ANTIBODY (ANA) - ANVISA Registration 10300390076
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 10300390076 and manufactured by BIOSYSTEMS S/A. 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.

Janaina dos Santos de Miranda
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Registration Details
10300390076
25351699208201851
00904728000148
Company Information
Dates and Status
Dec 17, 2018
VIGENTE
09/18/2025 19:00:01
ANTINUCLEAR ANTIBODY (ANA)
Anticorpos Anti-nDNA (nDNA)
ORGENTEC DIAGNOSTIKA GMBH
10300390824
Jul 08, 2019
ANTINUCLEAR ANTIBODY (ANA)
ANTICORPOS ANTI-nDNA IMUNOFLUORESCENCIA
SCIMEDX CORP
10225960022
Mar 19, 2001
ANTINUCLEAR ANTIBODY (ANA)
ANTI-DNA ENZIMAIMUNOENSAIO
HEMAGEN DIAGNOSTICS, INC.
10322610028
Apr 08, 2019
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
ANTI-nDNA IgG IMUNOFLUORESCENCIA
HEMAGEN DIAGNÓSTICS
10322610027
Apr 08, 2019
ANTINUCLEAR ANTIBODY (ANA)
INMUNOFLUOR ANTI-DNA
BIOCIENTIFICA S.A.
80189860018
Apr 05, 2005
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)
FamĂlia 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)
FamĂlia MAGLUMI® Triagem de ANA (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790431
Sep 16, 2024
ANTICORPO ANTINUCLEAR (ANA)
FamĂlia MAGLUMI® IgG anti-Scl-70 (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790433
Sep 16, 2024
ANTICORPO ANTINUCLEAR (ANA)
FamĂlia MAGLUMI® IgG anti-dsDNA (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790436
Sep 16, 2024