ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA) - ANVISA Registration 10322610027
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 10322610027 and manufactured by HEMAGEN DIAGNÓSTICS. The registration is held by KIMENZ EQUIPAMENTOS 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
10322610027
25351139942201946
72791445000148
Company Information
Dates and Status
Apr 08, 2019
VIGENTE
09/18/2025 19:00:01
ANTINUCLEAR ANTIBODY (ANA)
ANTICORPOS ANTI-nDNA IMUNOFLUORESCENCIA
SCIMEDX CORP
10225960022
Mar 19, 2001
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
DNA HEMAGLUTINACAO
HEMAGEN DIAGNOSTICS INC.
10280220153
Aug 09, 2001
ANTINUCLEAR ANTIBODY (ANA)
INMUNOFLUOR ANTI-DNA
BIOCIENTIFICA S.A.
80189860018
Apr 05, 2005
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
ENA Screening IgG
DIA.PRO DIAGNOSTIC BIOPROBES SRL
82532910009
Jan 02, 2023
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
ENA Screening IgG
DIA.PRO DIAGNOSTIC BIOPROBES SRL
81905510009
Feb 11, 2021
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