SYSTEMIC LUPUS ERYTHEMATOSUS - ANVISA Registration 10300390835
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 10300390835 and manufactured by ORGENTEC DIAGNOSTIKA GMBH. The registration is held by VYTTRA DIAGNOSTICOS S.A. 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
10300390835
25351703099201964
00904728000148
Company Information
Dates and Status
Dec 23, 2019
VIGENTE
09/18/2025 19:00:01
SYSTEMIC LUPUS ERYTHEMATOSUS
Anti-Rib-P
ORGENTEC DIAGNOSTIKA GMBH
10300390471
May 20, 2019
SYSTEMIC LUPUS ERYTHEMATOSUS
AUTOANTICORPOS RL/RK/RS
ORGENTEC DIAGNOSTIKA GMBH
10300390494
May 20, 2019
SYSTEMIC LUPUS ERYTHEMATOSUS
QUANTA Flash® Ribossomal P
INOVA DIAGNOSTICS, INC.
80003610477
Mar 16, 2015
ANTINUCLEAR ANTIBODY (ANA)
MAGLUMI Anti-Rib-P IgG (CLIA
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
80102512400
Mar 02, 2020
SYSTEMIC LUPUS ERYTHEMATOSUS
ANTICORPOS ANTI-DSDNA
BIOSYSTEMS S.A.
80213250659
Apr 24, 2017
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
Lupus Control
ROCHE DIAGNOSTICS GMBH
10287411454
Nov 04, 2019
LUPUS ERITEMATOSO SISTÊMICO
Anti-Rib-P
ORGENTEC DIAGNOSTIKA GMBH
10300390471
May 20, 2019
LUPUS ERITEMATOSO SISTÊMICO
AUTOANTICORPOS RL/RK/RS
ORGENTEC DIAGNOSTIKA GMBH
10300390494
May 20, 2019