SELF-TEST FOR ANTIBODIES TO HUMAN IMMUNODEFICIENCY VIRUS (HIV) - ANVISA Registration 80142170054
Access comprehensive regulatory information for SELF-TEST FOR ANTIBODIES TO HUMAN IMMUNODEFICIENCY VIRUS (HIV) in Brazil's medical device market through Pure Global AI's free database. This Risk Class IV medical device is registered under ANVISA number 80142170054 and manufactured by FUNDAÇÃO OSWALDO CRUZ. The registration is held by FUNDACAO OSWALDO CRUZ with validity until Mar 21, 2032.
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 ABBOTT RAPID DIAGNOSTICS JENA GMBH, CHEMBIO DIAGNOSTICS BRAZIL LTDA., 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
80142170054
25351888355202107
33781055000135
Company Information
Dates and Status
Mar 21, 2022
21/03/2032
09/18/2025 19:00:01
ANTIBODY FOR HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 AND TYPE 2 (HIV 1 AND HIV 2)
TESTE RAPIDO HIV-1/2 BIO MANGUINHOS
FUNDAÇÃO OSWALDO CRUZ
80142170019
Oct 29, 2004
ANTIBODY FOR HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 AND TYPE 2 (HIV 1 AND HIV 2)
TR HIV 1/2 - BIO-MANGUINHOS
Fundação Oswaldo Cruz - Instituto de Tecnologia em Imunobiológicos -
80142170076
Jul 28, 2025
SELF-TEST FOR ANTIBODIES TO HUMAN IMMUNODEFICIENCY VIRUS (HIV)
Família Teste Rápido HIV 1.2 (Sangue total) Para Autoteste
HANGZHOU ALLTEST BIOTECH CO. LTD
81325990349
May 20, 2024
SELF-TEST FOR ANTIBODIES TO HUMAN IMMUNODEFICIENCY VIRUS (HIV)
Família Teste Rápido HIV 1.2 (Sangue total) Para Autoteste
Not specified
81325990349
May 20, 2024
SELF-TEST FOR ANTIBODIES TO HUMAN IMMUNODEFICIENCY VIRUS (HIV)
Família Autoteste para HIV (Sangue total)
ACRO BIOTECH, INC. (MONTCLAIR)
81325990350
May 20, 2024
ABBOTT RAPID DIAGNOSTICS JENA GMBH• Germany
CHEMBIO DIAGNOSTICS BRAZIL LTDA.• Brazil
BIOSYNEX S.A.• France
ASSURE TECH. (HANGZHOU) CO., LTD• China
DPS INDUSTRIA, DISTRIBUICAO, COMERCIO, IMPORTACAO E EXPORTACAO LTDA• Brazil
AUTOTESTE PARA ANTICORPOS DO VÍRUS DE IMUNODEFICIÊNCIA HUMANA (HIV)
SAÚDE+
DPS INDUSTRIA, DISTRIBUICAO, COMERCIO, IMPORTACAO E EXPORTACAO LTDA
80861970054
Sep 15, 2025
AUTOTESTE PARA ANTICORPOS DO VÍRUS DE IMUNODEFICIÊNCIA HUMANA (HIV)
FaStep HIV Ab Saliva Assure Autoteste
ASSURE TECH. (HANGZHOU) CO., LTD
80885650093
Aug 25, 2025
AUTOTESTE PARA ANTICORPOS DO VÍRUS DE IMUNODEFICIÊNCIA HUMANA (HIV)
FaStep HIV Ab Saliva Assure Autoteste
Not specified
80885650093
Aug 25, 2025
AUTOTESTE PARA ANTICORPOS DO VÍRUS DE IMUNODEFICIÊNCIA HUMANA (HIV)
Autoteste de HIV OraQuick®
ORASURE TECHNOLOGIES INC
80430080021
May 26, 2025
AUTOTESTE PARA ANTICORPOS DO VÍRUS DE IMUNODEFICIÊNCIA HUMANA (HIV)
Autoteste de HIV OraQuick®
Not specified
80430080021
May 26, 2025