ANTINUCLEAR ANTIBODY (ANA) - ANVISA Registration 80003610475
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 80003610475 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
🇧🇷 Brazil Regulatory Expert
Need help with your Brazil registration?
Contact Pure Global Brazil TeamDevice Details
Registration Details
80003610475
25351776828201406
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
INOVA DIAGNOSTICS, INC.
80003610469
Jan 19, 2015
ANTINUCLEAR ANTIBODY (ANA)
QUANTA Flash® Ro60
INOVA DIAGNOSTICS, INC.
80003610463
Dec 22, 2014
ANTINUCLEAR ANTIBODY (ANA)
QUANTA Flash® DFS70
INOVA DIAGNOSTICS, INC
80003610439
Nov 03, 2014
ANTINUCLEAR ANTIBODY (ANA)
QUANTA Flash® CTD Screen Plus
INOVA DIAGNOSTICS, INC
80003610480
Mar 16, 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)
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