ANTICYTOPLASMIC ANTIBODY - ANVISA Registration 80416660137
Access comprehensive regulatory information for ANTICYTOPLASMIC ANTIBODY in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 80416660137 and manufactured by ORGENTEC DIAGNOSTIKA GMBH. The registration is held by SEBIA IMPORTAÇÕES COMERCIALIZAÇÃO E DISTRIBUIÇÃO DE APARELHOS E REATIVOS PARA DIAGNÓSTICO IN VITRO 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, INOVA DIAGNOSTICS, INC., 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
80416660137
25351013292202396
08576331000186
Company Information
Dates and Status
Jan 30, 2023
VIGENTE
09/18/2025 19:00:01
ANTICYTOPLASMIC ANTIBODY
ANCA SCREEN
ORGENTEC DIAGNOSTIKA GMBH
10300390818
Jul 08, 2019
ANTICYTOPLASMIC ANTIBODY
ImmuLisa ANCA Screen ELISA
IMMCO DIAGNOSTICS, INC.
80944340039
May 06, 2019
ANTICYTOPLASMIC ANTIBODY
Anti-PR3 hs
ORGENTEC DIAGNOSTIKA GMBH
10300390606
May 20, 2019
ANTICYTOPLASMIC ANTIBODY
Anti-PR3 hs
ORGENTEC DIAGNOSTIKA GMBH
10300390603
May 20, 2019
ANTICYTOPLASMIC ANTIBODY
cANCA IFA plus
GA GENERIC ASSAYS GMBH
80836930098
Jul 29, 2021
ORGENTEC DIAGNOSTIKA GMBH• Germany
INOVA DIAGNOSTICS, INC.• United States of America
IMMCO DIAGNOSTICS, INC.• United States of America
EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG• Germany
INOVA DIAGNOSTICS, INC .• United States of America
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82910510004
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AESKU DIAGNOSTICS GMBH & CO. KG
82910510003
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SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
80102513332
Dec 23, 2024
ANTICORPO ANTICITOPLASMÁTICO
Família MAGLUMI® IgG Anti-MPO (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790415
Aug 05, 2024
ANTICORPO ANTICITOPLASMÁTICO
Granulocyte Mosaic 25
EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG
10338930291
Sep 04, 2023