ANTINUCLEAR ANTIBODY (ANA) - ANVISA Registration 80189860018
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 80189860018 and manufactured by BIOCIENTIFICA S.A.. The registration is held by ANFLA PRODUTOS PARA DIAGNOSTICOS LABORATORIAL 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.

Janaina dos Santos de Miranda
🇧🇷 Brazil Regulatory Expert
Need help with your Brazil registration?
Contact Pure Global Brazil TeamDevice Details
Registration Details
80189860018
25351283079200487
05774798000142
Company Information
Dates and Status
Apr 05, 2005
VIGENTE
09/18/2025 19:00:01
ANTINUCLEAR ANTIBODY (ANA)
ANTICORPOS ANTI-nDNA IMUNOFLUORESCENCIA
SCIMEDX CORP
10225960022
Mar 19, 2001
ANTINUCLEAR ANTIBODY (ANA)
INMUNOFLUOR ANA HEP-2
BIOCIENTIFICA S.A.
80189860017
Mar 29, 2005
ANTINUCLEAR ANTIBODY (ANA)
IMUNOCON ANTI-DNA
WAMA PRODUTOS PARA LABORATORIO LTDA
10310030068
May 28, 2003
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
ANTI-nDNA IgG IMUNOFLUORESCENCIA
HEMAGEN DIAGNÓSTICS
10322610027
Apr 08, 2019
ANTINUCLEAR ANTIBODY (ANA)
FLUORESCENT NDNA
IMMUNO CONCEPTS N.A.,LTD.
10300390644
May 20, 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)
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