SYSTEMIC LUPUS ERYTHEMATOSUS - ANVISA Registration 80003610477
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 80003610477 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
80003610477
25351777515201474
02004662000165
Company Information
Dates and Status
Mar 16, 2015
VIGENTE
09/18/2025 19:00:01
SYSTEMIC LUPUS ERYTHEMATOSUS
Quanta Flash® dsDNA
INOVA DIAGNOSTICS, INC.
80003610418
Aug 18, 2014
SYSTEMIC LUPUS ERYTHEMATOSUS
QUANTA Flash® Ro60 Calibradores
INOVA DIAGNOSTICS, INC.
80003610465
Dec 22, 2014
SYSTEMIC LUPUS ERYTHEMATOSUS
Quanta Lite Sm
INOVA DIAGNOSTICS, INC.
80003610385
Jun 10, 2014
SYSTEMIC LUPUS ERYTHEMATOSUS
Quanta Lite Cromatina Elisa
INOVA DIAGNOSTICS, INC.
80003610391
Jun 20, 2014
SYSTEMIC LUPUS ERYTHEMATOSUS
Quanta Lite RNP Elisa
INOVA DIAGNOSTICS, INC.
80003610383
Jun 10, 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