ANTINUCLEAR ANTIBODY (ANA) - ANVISA Registration 80003610229
Access comprehensive regulatory information for ANTINUCLEAR ANTIBODY (ANA) in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 80003610229 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., ORGENTEC DIAGNOSTIKA GMBH, 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
80003610229
25351871874200835
02004662000165
Company Information
Dates and Status
Sep 24, 2009
VIGENTE
09/18/2025 19:00:01
ANTINUCLEAR ANTIBODY (ANA)
QUANTA Lite™ Kit ENA ELISA
INOVA DIAGNOSTICS , INC.
80003610233
Sep 24, 2009
ANTINUCLEAR ANTIBODY (ANA)
QUANTA Lite® sp100 Elisa
INOVA DIAGNOSTICS, INC.
80003610472
Mar 02, 2015
ANTINUCLEAR ANTIBODY (ANA)
QUANTA LiteTM RNA Polimerase III Elisa
INOVA DIAGNOSTICS, INC.
80003610409
Aug 04, 2014
ANTINUCLEAR ANTIBODY (ANA)
QUANTA Lite® gp210 Elisa
INOVA DIAGNOSTICS, INC.
80003610448
Dec 15, 2014
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
QUANTA Flash® SS-B
INOVA DIAGNOSTICS, INC
80003610462
Dec 22, 2014
ANTICORPO ANTINUCLEAR (ANA)
Família MAGLUMI Antinucleossomos para IgG (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
80102513500
Aug 11, 2025
ANTICORPO ANTINUCLEAR (ANA)
AESKUSLIDES ANA HEp-2
AESKU DIAGNOSTICS GMBH & CO. KG
82910510002
Apr 07, 2025
ANTICORPO ANTINUCLEAR (ANA)
Família MAGLUMI® Triagem de ANA (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790431
Sep 16, 2024
ANTICORPO ANTINUCLEAR (ANA)
Família MAGLUMI® IgG anti-Scl-70 (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790433
Sep 16, 2024
ANTICORPO ANTINUCLEAR (ANA)
Família MAGLUMI® IgG anti-dsDNA (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790436
Sep 16, 2024