ANTINUCLEAR ANTIBODY (ANA) - ANVISA Registration 80003610498
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 80003610498 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
š§š· Brazil Regulatory Expert
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Registration Details
80003610498
25351135817201563
02004662000165
Company Information
Dates and Status
May 11, 2015
VIGENTE
09/18/2025 19:00:01
ANTINUCLEAR ANTIBODY (ANA)
NOVA LiteĀ® kit dsDNA Crithidia luciliae com DAPI
INOVA DIAGNOSTICS, INC.
80003610497
May 11, 2015
ANTINUCLEAR ANTIBODY (ANA)
NOVA LiteĀ® DAPI ANA Kit
INOVA DIAGNOSTICS, INC.
80003610513
Dec 14, 2015
ANTINUCLEAR ANTIBODY (ANA)
NOVA Lite DAPI dsDNA Crithidia luciliae Kit
INOVA DIAGNOSTICS, INC
80003610607
Sep 29, 2022
ANTINUCLEAR ANTIBODY (ANA)
Nova Lite HEp-2
INOVA DIAGNOSTICS , INC.
80003610328
Mar 25, 2013
ANTINUCLEAR ANTIBODY (ANA)
NOVA LiteĀ® ANA KSL
INOVA DIAGNOSTICS, INC.
80003610484
Mar 23, 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)
FamĆlia 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)
FamĆlia MAGLUMIĀ® Triagem de ANA (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790431
Sep 16, 2024
ANTICORPO ANTINUCLEAR (ANA)
FamĆlia MAGLUMIĀ® IgG anti-Scl-70 (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790433
Sep 16, 2024
ANTICORPO ANTINUCLEAR (ANA)
FamĆlia MAGLUMIĀ® IgG anti-dsDNA (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790436
Sep 16, 2024