ANTINUCLEAR ANTIBODY (ANA) - ANVISA Registration 80003610479
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 80003610479 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
80003610479
25351777543201471
02004662000165
Company Information
Dates and Status
Mar 16, 2015
VIGENTE
09/18/2025 19:00:01
ANTINUCLEAR ANTIBODY (ANA)
QUANTA Flash® RNP Calibradores
INOVA DIAGNOSTICS, INC.
80003610502
Jun 22, 2015
ANTINUCLEAR ANTIBODY (ANA)
QUANTA Flash® Sm Calibradores
INOVA DIAGNOSTICS, INC.
80003610467
Jan 19, 2015
ANTINUCLEAR ANTIBODY (ANA)
QUANTA Flash® Ribossomal P Controles
INOVA DIAGNOSTICS, INC .
80003610478
Mar 16, 2015
ANTINUCLEAR ANTIBODY (ANA)
Quanta Flash® dsDNA Calibradores
INOVA DIAGNOSTICS , INC.
80003610416
Aug 18, 2014
ANTINUCLEAR ANTIBODY (ANA)
QUANTA Flash® DFS70 Calibradores
INOVA DIAGNOSTICS, INC.
80003610446
Dec 08, 2014
INOVA DIAGNOSTICS, INC.• United States of America
ORGENTEC DIAGNOSTIKA GMBH• Germany
DIA.PRO DIAGNOSTIC BIOPROBES SRL• Italy
PHADIA AB• Sweden
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.• China
ANTICORPO ANTINUCLEAR (ANA)
FamÃlia 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)
FamÃlia MAGLUMI® Triagem de ANA (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790431
Sep 16, 2024
ANTICORPO ANTINUCLEAR (ANA)
FamÃlia MAGLUMI® IgG anti-Scl-70 (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790433
Sep 16, 2024
ANTICORPO ANTINUCLEAR (ANA)
FamÃlia MAGLUMI® IgG anti-dsDNA (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790436
Sep 16, 2024