ANTINUCLEAR ANTIBODY (ANA) - ANVISA Registration 10300390735
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 10300390735 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.

Janaina dos Santos de Miranda
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Registration Details
10300390735
25351253241201919
00904728000148
Company Information
Dates and Status
May 20, 2019
VIGENTE
09/18/2025 19:00:01
ANTINUCLEAR ANTIBODY (ANA)
ANA Detect
ORGENTEC DIAGNOSTIKA GMBH
10300390819
Jul 08, 2019
ANTINUCLEAR ANTIBODY (ANA)
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80332010034
Aug 30, 2010
ANTINUCLEAR ANTIBODY (ANA)
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10310030148
Mar 11, 2013
ANTINUCLEAR ANTIBODY (ANA)
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IMMCO DIAGNOSTICS, INC.
80944340021
Apr 15, 2019
ANTINUCLEAR ANTIBODY (ANA)
QUANTA Lite™ Kit ENA ELISA
INOVA DIAGNOSTICS , INC.
80003610233
Sep 24, 2009
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