ANTINUCLEAR ANTIBODY (ANA) - ANVISA Registration 10300390666
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 10300390666 and manufactured by ORGENTEC DIAGNOSTIKA GMBH. 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., DIA.PRO DIAGNOSTIC BIOPROBES SRL, 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
10300390666
25351250674201912
00904728000148
Company Information
Dates and Status
May 20, 2019
VIGENTE
09/18/2025 19:00:01
ANTINUCLEAR ANTIBODY (ANA)
ANTI-ssDNA
ORGENTEC DIAGNOSTIKA GMBH
10300390600
May 20, 2019
ANTINUCLEAR ANTIBODY (ANA)
ssDNA IgG
EUROIMMUN AG
81148560045
Mar 20, 2017
ANTINUCLEAR ANTIBODY (ANA)
IgG anti dsDNA
DIA.PRO DIAGNOSTIC BIOPROBES SRL
81905510010
Feb 11, 2021
ANTINUCLEAR ANTIBODY (ANA)
IgG anti dsDNA
DIA.PRO DIAGNOSTIC BIOPROBES SRL
82532910012
Jan 02, 2023
ANTINUCLEAR ANTIBODY (ANA)
IgG anti-dsDNA
DIA.PRO DIAGNOSTIC BIOPROBES SRL
80915630024
Mar 12, 2018
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