ANTINUCLEAR ANTIBODY (ANA) - ANVISA Registration 80464810899
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 80464810899 and manufactured by GA GENERIC ASSAYS GMBH. The registration is held by ARGOSLAB DISTRIBUIDORA DE PRODUTOS PARA LABORATÓRIOS 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.

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Registration Details
80464810899
25351958771202414
09377976000152
Company Information
Dates and Status
Mar 04, 2024
VIGENTE
09/18/2025 19:00:01
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
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SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
80102513501
Aug 11, 2025
ANTINUCLEAR ANTIBODY (ANA)
nDNA IFA plus
GA GENERIC ASSAYS GMBH
80836930097
Jul 22, 2021
ANTINUCLEAR ANTIBODY (ANA)
DotDiver Quantrix ANA
GA - GENERIC ASSAYS
80464810365
Apr 07, 2014
ANTINUCLEAR ANTIBODY (ANA)
ANA HEp-2 plus
GA GENERIC ASSAYS GMBH
80464810683
Nov 25, 2019
ANTINUCLEAR ANTIBODY (ANA)
MAGLUMI IgG anti-Scl-70 (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
80102512392
Feb 17, 2020
ANTICORPO ANTINUCLEAR (ANA)
Família 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)
Família MAGLUMI® Triagem de ANA (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790431
Sep 16, 2024
ANTICORPO ANTINUCLEAR (ANA)
Família MAGLUMI® IgG anti-Scl-70 (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790433
Sep 16, 2024
ANTICORPO ANTINUCLEAR (ANA)
Família MAGLUMI® IgG anti-dsDNA (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
81504790436
Sep 16, 2024