SELF-TEST FOR ANTIBODIES TO HUMAN IMMUNODEFICIENCY VIRUS (HIV) - ANVISA Registration 80686360310
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 80686360310 and manufactured by BIOSYNEX S.A.. The registration is held by MANDALA BRASIL IMPORTACAO E DISTRIBUICAO DE PRODUTO MEDICO HOSPITALAR LTDA with validity until Dec 28, 2030.
This page provides complete technical specifications for 2 related devices, 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.

Janaina dos Santos de Miranda
🇧🇷 Brazil Regulatory Expert
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Contact Pure Global Brazil TeamRelated Devices (2)
Registration Details
80686360310
25351292807202061
09117476000181
Company Information
Dates and Status
Dec 28, 2020
28/12/2030
09/18/2025 19:00:01
SELF-TEST FOR ANTIBODIES TO HUMAN IMMUNODEFICIENCY VIRUS (HIV)
ALERTA
WAMA PRODUTOS PARA LABORATORIO LTDA
10310030194
Apr 09, 2018
SELF-TEST FOR ANTIBODIES TO HUMAN IMMUNODEFICIENCY VIRUS (HIV)
SAÚDE+
DPS INDUSTRIA, DISTRIBUICAO, COMERCIO, IMPORTACAO E EXPORTACAO LTDA
80861970054
Sep 15, 2025
SELF-TEST FOR ANTIBODIES TO HUMAN IMMUNODEFICIENCY VIRUS (HIV)
FaStep HIV Ab Saliva Assure Autoteste
ASSURE TECH. (HANGZHOU) CO., LTD
80885650093
Aug 25, 2025
SELF-TEST FOR ANTIBODIES TO HUMAN IMMUNODEFICIENCY VIRUS (HIV)
FaStep HIV Ab Saliva Assure Autoteste
Not specified
80885650093
Aug 25, 2025
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
ASSURE TECH. (HANGZHOU) CO., LTD• China
DPS INDUSTRIA, DISTRIBUICAO, COMERCIO, IMPORTACAO E EXPORTACAO LTDA• Brazil
ORASURE TECHNOLOGIES INC• United States of America
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