ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA) - ANVISA Registration 80003610476
Access comprehensive regulatory information for ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA) in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 80003610476 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 ORGENTEC DIAGNOSTIKA GMBH, SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD., 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
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Registration Details
80003610476
25351776899201451
02004662000165
Company Information
Dates and Status
Mar 16, 2015
VIGENTE
09/18/2025 19:00:01
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
QUANTA Flash® ENA7 Controles
INOVA DIAGNOSTICS, INC .
80003610442
Nov 03, 2014
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
QUANTA Flash® SS-B Controles
INOVA DIAGNOSTICS, INC .
80003610461
Dec 22, 2014
ANTINUCLEAR ANTIBODY (ANA)
QUANTA Flash® Sm Controles
INOVA DIAGNOSTICS, INC .
80003610468
Jan 19, 2015
ANTINUCLEAR ANTIBODY (ANA)
QUANTA Flash® Scl-70 Controles
INOVA DIAGNOSTICS, INC.
80003610490
Apr 06, 2015
ANTINUCLEAR ANTIBODY (ANA)
QUANTA Flash® Ro60 Controles
INOVA DIAGNOSTICS, INC.
80003610460
Dec 22, 2014
ANTICORPO ANTI-ANTÍGENOS NUCLEARES EXTRAÍVEIS (ENA)
Família MAGLUMI IgG anti-PM-Scl (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
80102513501
Aug 11, 2025
ANTICORPO ANTI-ANTÍGENOS NUCLEARES EXTRAÍVEIS (ENA)
Família MAGLUMI IgG Anti-Ro-52 (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
80102513502
Aug 11, 2025
ANTICORPO ANTI-ANTÍGENOS NUCLEARES EXTRAÍVEIS (ENA)
Família MAGLUMI® Triagem de ENA (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790434
Sep 16, 2024
ANTICORPO ANTI-ANTÍGENOS NUCLEARES EXTRAÍVEIS (ENA)
Família MAGLUMI® Anti-Jo-1 IgG (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790424
Aug 26, 2024
ANTICORPO ANTI-ANTÍGENOS NUCLEARES EXTRAÍVEIS (ENA)
Família MAGLUMI® Anti-SS-A/Ro IgG (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790426
Aug 26, 2024