ANTINUCLEAR ANTIBODY (ANA) - ANVISA Registration 80263710034
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 80263710034 and manufactured by ZEUS SCIENTIFIC INC. The registration is held by VIRION 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.

Janaina dos Santos de Miranda
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Registration Details
80263710034
25351337747201053
04762623000152
Company Information
Dates and Status
Oct 17, 2011
VIGENTE
09/18/2025 19:00:01
ANTINUCLEAR ANTIBODY (ANA)
HEP-2 ANA TEST KIT
DTS – DIAGNOSTIC & TECHNICAL SERVICE C.C.
80016880002
Mar 20, 2006
ANTINUCLEAR ANTIBODY (ANA)
ANA HEp-2 TEST SYSTEM
BIONENTERPRISES LTDA
10259610054
Apr 19, 2005
ANTINUCLEAR ANTIBODY (ANA)
ImmuGlo HEp-2 Cells Anti Nuclear Antibody IFA Kit
IMMCO DIAGNOSTICS, INC.
80944340030
Apr 15, 2019
ANTINUCLEAR ANTIBODY (ANA)
ANA HEp-2 plus
GA GENERIC ASSAYS GMBH
80464810683
Nov 25, 2019
ANTINUCLEAR ANTIBODY (ANA)
AESKUSLIDES ANA-HEp-2
AESKU DIAGNOSTICS GMBH & CO. KG
10259610165
Jun 29, 2015
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
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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
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ANTICORPO ANTINUCLEAR (ANA)
FamÃlia MAGLUMI® IgG anti-dsDNA (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790436
Sep 16, 2024