ANTINUCLEAR ANTIBODY (ANA) - ANVISA Registration 80189860017
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 80189860017 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
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Registration Details
80189860017
25351282798200481
05774798000142
Company Information
Dates and Status
Mar 29, 2005
VIGENTE
09/18/2025 19:00:01
ANTINUCLEAR ANTIBODY (ANA)
ANA/HEp-2 IgG (ANTICORPOS ANTINUCLEARES IgG) IMUNOFLUORESCENCIA
HEMAGEN DIAGNOSTICS, INC.
10322610029
Apr 08, 2019
ANTINUCLEAR ANTIBODY (ANA)
ANTICORPOS ANTI-NUCLEARES HEp-2 (ANA HEP - 2)
BIOSYSTEMS S/A
10300390074
Dec 17, 2018
ANTINUCLEAR ANTIBODY (ANA)
IF: HEp-2
EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG
10338930080
Feb 03, 2014
ANTINUCLEAR ANTIBODY (ANA)
INMUNOFLUOR ANTI-DNA
BIOCIENTIFICA S.A.
80189860018
Apr 05, 2005
ANTINUCLEAR ANTIBODY (ANA)
ANA HEp-2 TEST SYSTEM
BIONENTERPRISES LTDA
10259610054
Apr 19, 2005
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