SYSTEMIC LUPUS ERYTHEMATOSUS - ANVISA Registration 80003610394
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 80003610394 and manufactured by INOVA DIAGNOSTICS, INC.. The registration is held by WERFEN MEDICAL 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
80003610394
25351255700201448
02004662000165
Company Information
Dates and Status
Jul 07, 2014
VIGENTE
09/18/2025 19:00:01
SYSTEMIC LUPUS ERYTHEMATOSUS
Quanta Lite SS-B Elisa
INOVA DIAGNOSTICS , INC.
80003610386
Jun 10, 2014
SYSTEMIC LUPUS ERYTHEMATOSUS
Quanta Lite ß2 GPI IgM Elisa
INOVA DIAGNOSTICS, INC
80003610377
Apr 28, 2014
SYSTEMIC LUPUS ERYTHEMATOSUS
Quanta Lite RNP Elisa
INOVA DIAGNOSTICS, INC.
80003610383
Jun 10, 2014
SYSTEMIC LUPUS ERYTHEMATOSUS
Quanta Lite beta-2 GPI IgG
INOVA DIAGNOSTICS, INC.
80003610389
Jun 20, 2014
SYSTEMIC LUPUS ERYTHEMATOSUS
Quanta Lite Cromatina Elisa
INOVA DIAGNOSTICS, INC.
80003610391
Jun 20, 2014
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