ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA) - ANVISA Registration 10280220153
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 10280220153 and manufactured by HEMAGEN DIAGNOSTICS INC.. The registration is held by HEMAGEN DIAGNOSTICOS COMERCIO IMP E EXPORTACAO 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
10280220153
253510081550153
64002686000132
Company Information
Dates and Status
Aug 09, 2001
VIGENTE
09/18/2025 19:00:01
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
ENA SCREENING 4 HEMAGLUTINACAO
HEMAGEN DIAGNOSTICS INC.
10280220165
Aug 09, 2001
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
RNP/Sm HEMAGLUTINACAO
HEMAGEN DIAGNOSTICS INC.
10280220158
Aug 09, 2001
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
ScI/70 HEMAGLUTINACAO
HEMAGEN DIAGNOSTICS INC.
10280220161
Aug 09, 2001
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
SS-A/SS-B-HEMAGLUTINACAO
HEMAGEN DIAGNOSTICS INC.
10280220160
Aug 09, 2001
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
JO-1 HEMAGLUTINACAO
HEMAGEN DIAGNOSTICS INC.
10280220152
Aug 09, 2001
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