SYSTEMIC LUPUS ERYTHEMATOSUS - ANVISA Registration 80213250646
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 80213250646 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.

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Registration Details
80213250646
25351155591201705
64128853000196
Company Information
Dates and Status
Apr 24, 2017
VIGENTE
09/18/2025 19:00:01
SYSTEMIC LUPUS ERYTHEMATOSUS
ENA 6- SCREENING
BIOSYSTEMS S.A.
80213250693
Apr 24, 2017
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
ENA-4-PROFILE
ORGENTEC DIAGNOSTIKA GMBH
10300390732
May 20, 2019
SYSTEMIC LUPUS ERYTHEMATOSUS
ANA - SCREENING
BIOSYSTEMS S/A
80213250670
Apr 24, 2017
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
ENA-6-PROFILE
ORGENTEC DIAGNOSTIKA GMBH
10300390617
May 20, 2019
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
ENA 6 Parameters Profile
DIA.PRO DIAGNOSTIC BIOPROBES SRL
80915630021
Mar 12, 2018
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