ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA) - ANVISA Registration 80003610567
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 80003610567 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
Need help with your Brazil registration?
Contact Pure Global Brazil TeamDevice Details
Registration Details
80003610567
25351856785201856
02004662000165
Company Information
Dates and Status
Mar 18, 2019
VIGENTE
09/18/2025 19:00:01
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
QUANTA Flash® ENA7 Calibradores
INOVA DIAGNOSTICS, INC
80003610440
Nov 03, 2014
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
QUANTA Flash® RNP Controles
INOVA DIAGNOSTICS, INC .
80003610476
Mar 16, 2015
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
QUANTA Flash® ENA7
INOVA DIAGNOSTICS, INC
80003610441
Nov 03, 2014
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
QUANTA Flash® SS-B Calibradores
INOVA DIAGNOSTICS, INC.
80003610464
Dec 22, 2014
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
QUANTA Flash® Scl-70 Calibradores
INOVA DIAGNOSTICS, INC.
80003610496
Apr 13, 2015
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