SYSTEMIC LUPUS ERYTHEMATOSUS - ANVISA Registration 80102512396
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 80102512396 and manufactured by SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.. The registration is held by VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS 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
80102512396
25351670246201911
04718143000194
Company Information
Dates and Status
Feb 26, 2020
VIGENTE
09/18/2025 19:00:01
ANTINUCLEAR ANTIBODY (ANA)
Família MAGLUMI® IgG anti-dsDNA (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790436
Sep 16, 2024
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
MAGLUMI IgG Anti-Sm (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
80102512405
Mar 02, 2020
ANTINUCLEAR ANTIBODY (ANA)
MAGLUMI IgG anti-Scl-70 (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
80102512392
Feb 17, 2020
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
MAGLUMI IgG Anti-nRNP/Sm (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
80102512397
Feb 26, 2020
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
MAGLUMI IgG Anti-SS-B (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
80102512403
Mar 02, 2020
LUPUS ERITEMATOSO SISTÊMICO
FAMILIA iFLASH-dsDNA IgG e dsDNA IgG CONTROL
SHENZHEN YHLO BIOTECH CO., LTD.
80867150103
Jul 01, 2021
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
LUPUS ERITEMATOSO SISTÊMICO
AUTOANTICORPOS RL/RK/RS
ORGENTEC DIAGNOSTIKA GMBH
10300390494
May 20, 2019