ANTINUCLEAR ANTIBODY (ANA) - ANVISA Registration 80003610415
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 80003610415 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.

Janaina dos Santos de Miranda
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Registration Details
80003610415
25351332068201417
02004662000165
Company Information
Dates and Status
Aug 18, 2014
VIGENTE
09/18/2025 19:00:01
ANTINUCLEAR ANTIBODY (ANA)
Quanta Flash® dsDNA Calibradores
INOVA DIAGNOSTICS , INC.
80003610416
Aug 18, 2014
ANTINUCLEAR ANTIBODY (ANA)
QUANTA Flash® Sm Controles
INOVA DIAGNOSTICS, INC .
80003610468
Jan 19, 2015
ANTINUCLEAR ANTIBODY (ANA)
QUANTA Flash® Ro60 Controles
INOVA DIAGNOSTICS, INC.
80003610460
Dec 22, 2014
ANTINUCLEAR ANTIBODY (ANA)
QUANTA Flash® DFS70 Controles
INOVA DIAGNOSTICS, INC
80003610447
Dec 08, 2014
ANTINUCLEAR ANTIBODY (ANA)
Quanta Flash® Jo-1 Controles
INOVA DIAGNOSTICS, INC.
80003610492
Apr 06, 2015
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)
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80102513500
Aug 11, 2025
ANTICORPO ANTINUCLEAR (ANA)
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ANTICORPO ANTINUCLEAR (ANA)
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81504790431
Sep 16, 2024
ANTICORPO ANTINUCLEAR (ANA)
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ANTICORPO ANTINUCLEAR (ANA)
FamÃlia MAGLUMI® IgG anti-dsDNA (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790436
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