SYSTEMIC LUPUS ERYTHEMATOSUS - ANVISA Registration 80213250659
Access comprehensive regulatory information for SYSTEMIC LUPUS ERYTHEMATOSUS in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 80213250659 and manufactured by BIOSYSTEMS S.A.. The registration is held by PHAREBEE DIAGNOSTICOS COMERCIO IMPORTACAO E EXPORTACAO DE PRODUTOS 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 INOVA DIAGNOSTICS, INC., EUROIMMUN AG, 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
80213250659
25351155949201701
64128853000196
Company Information
Dates and Status
Apr 24, 2017
VIGENTE
09/18/2025 19:00:01
SYSTEMIC LUPUS ERYTHEMATOSUS
AUTOANTICORPOS RL/RK/RS
ORGENTEC DIAGNOSTIKA GMBH
10300390494
May 20, 2019
SYSTEMIC LUPUS ERYTHEMATOSUS
MAGLUMI IgG anti-dsDNA (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
80102512396
Feb 26, 2020
SYSTEMIC LUPUS ERYTHEMATOSUS
FAMILIA iFLASH-dsDNA IgG e dsDNA IgG CONTROL
SHENZHEN YHLO BIOTECH CO., LTD.
80867150103
Jul 01, 2021
ANTINUCLEAR ANTIBODY (ANA)
IgG anti dsDNA
DIA.PRO DIAGNOSTIC BIOPROBES SRL
81905510010
Feb 11, 2021
ANTINUCLEAR ANTIBODY (ANA)
IgG anti dsDNA
DIA.PRO DIAGNOSTIC BIOPROBES SRL
82532910012
Jan 02, 2023
LUPUS ERITEMATOSO SISTÊMICO
FAMILIA iFLASH-dsDNA IgG e dsDNA IgG CONTROL
SHENZHEN YHLO BIOTECH CO., LTD.
80867150103
Jul 01, 2021
LUPUS ERITEMATOSO SISTÊMICO
MAGLUMI IgG anti-dsDNA (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
80102512396
Feb 26, 2020
LUPUS ERITEMATOSO SISTÊMICO
ANTI-RIB P
ORGENTEC DIAGNOSTIKA GMBH
10300390835
Dec 23, 2019
LUPUS ERITEMATOSO SISTÊMICO
Lupus Control
ROCHE DIAGNOSTICS GMBH
10287411454
Nov 04, 2019
LUPUS ERITEMATOSO SISTÊMICO
Anti-Rib-P
ORGENTEC DIAGNOSTIKA GMBH
10300390471
May 20, 2019