ANTINUCLEAR ANTIBODY (ANA) - ANVISA Registration 10300390797
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 10300390797 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
10300390797
25351250418201925
00904728000148
Company Information
Dates and Status
Jul 08, 2019
VIGENTE
09/18/2025 19:00:01
ANTINUCLEAR ANTIBODY (ANA)
ANTICORPOS ANTI-NUCLEARES HEp-2 (ANA HEP - 2)
BIOSYSTEMS S/A
10300390074
Dec 17, 2018
ANTINUCLEAR ANTIBODY (ANA)
INMUNOFLUOR ANA HEP-2
BIOCIENTIFICA S.A.
80189860017
Mar 29, 2005
ANTINUCLEAR ANTIBODY (ANA)
ANA/HEp-2 IgG (ANTICORPOS ANTINUCLEARES IgG) IMUNOFLUORESCENCIA
HEMAGEN DIAGNOSTICS, INC.
10322610029
Apr 08, 2019
ANTINUCLEAR ANTIBODY (ANA)
IMUNOCON ANAHEP-2
WAMA PRODUTOS PARA LABORATORIO LTDA
10310030065
May 28, 2003
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