ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA) - ANVISA Registration 80263710024
Access comprehensive regulatory information for ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA) in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 80263710024 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 ORGENTEC DIAGNOSTIKA GMBH, SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD., 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
🇧🇷 Brazil Regulatory Expert
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Registration Details
80263710024
25351338440201033
04762623000152
Company Information
Dates and Status
Dec 07, 2010
VIGENTE
09/18/2025 19:00:01
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
ImmuLisa SS-B (La) ANTIBODY ELISA
IMMCO DIAGNOSTICS, INC.
80944340024
Apr 15, 2019
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
SS-B (La) - EIA
HEMAGEN DIAGNOSTICS INC.
10322610041
Apr 08, 2019
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
ANTI-SSB
ORGENTEC DIAGNOSTIKA GMBH
10300390512
May 20, 2019
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
Anti-SS-B
ORGENTEC DIAGNOSTIKA GMBH
10300390484
May 20, 2019
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
Anti-SS-B
ORGENTEC DIAGNOSTIKA GMBH
80416660120
Jan 09, 2023
ANTICORPO ANTI-ANTÍGENOS NUCLEARES EXTRAÍVEIS (ENA)
Família MAGLUMI IgG anti-PM-Scl (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
80102513501
Aug 11, 2025
ANTICORPO ANTI-ANTÍGENOS NUCLEARES EXTRAÍVEIS (ENA)
Família MAGLUMI IgG Anti-Ro-52 (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
80102513502
Aug 11, 2025
ANTICORPO ANTI-ANTÍGENOS NUCLEARES EXTRAÍVEIS (ENA)
Família MAGLUMI® Triagem de ENA (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790434
Sep 16, 2024
ANTICORPO ANTI-ANTÍGENOS NUCLEARES EXTRAÍVEIS (ENA)
Família MAGLUMI® Anti-Jo-1 IgG (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790424
Aug 26, 2024
ANTICORPO ANTI-ANTÍGENOS NUCLEARES EXTRAÍVEIS (ENA)
Família MAGLUMI® Anti-SS-A/Ro IgG (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790426
Aug 26, 2024