ANTINUCLEAR ANTIBODY (ANA) - ANVISA Registration 80867150102
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 80867150102 and manufactured by SHENZHEN YHLO BIOTECH CO., LTD.. The registration is held by BIOMOLECULAR TECHNOLOGY COMÉRCIO, IMPORTAÇÃO, EXPORTAÇÃO E DISTRIBUIÇÃO DE MATERIAIS MÉDICOS E LABORATORIAIS LTDA - EPP 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
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Registration Details
80867150102
25351662196202112
07767477000146
Company Information
Dates and Status
Jul 01, 2021
VIGENTE
09/18/2025 19:00:01
SYSTEMIC LUPUS ERYTHEMATOSUS
FAMILIA iFLASH-dsDNA IgG e dsDNA IgG CONTROL
SHENZHEN YHLO BIOTECH CO., LTD.
80867150103
Jul 01, 2021
ANTINUCLEAR ANTIBODY (ANA)
QUANTA Flash® Sm Controles
INOVA DIAGNOSTICS, INC .
80003610468
Jan 19, 2015
ANTINUCLEAR ANTIBODY (ANA)
QUANTA Flash® CTD Screen Plus Controles
INOVA DIAGNOSTICS, INC .
80003610488
Mar 23, 2015
ANTINUCLEAR ANTIBODY (ANA)
QUANTA Flash® Ro60 Controles
INOVA DIAGNOSTICS, INC.
80003610460
Dec 22, 2014
ANTINUCLEAR ANTIBODY (ANA)
QUANTA Flash® DFS70 Controles
INOVA DIAGNOSTICS, INC
80003610447
Dec 08, 2014
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