SELF-TEST FOR ANTIBODIES TO HUMAN IMMUNODEFICIENCY VIRUS (HIV) - ANVISA Registration 80430080021
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 80430080021 and manufactured by ORASURE TECHNOLOGIES INC. The registration is held by CMW SAUDE E TECNOLOGIA IMPORTAÇAO E EXPORTAÇAO LTDA - ME with validity until May 26, 2035.
This page provides complete technical specifications for 2 related devices, regulatory compliance details, 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.
Related Devices (2)
Registration Details
80430080021
25351442308202293
07430231000184
Company Information
Dates and Status
May 26, 2025
26/05/2035
09/18/2025 19:00:01
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)
Família Teste Rápido HIV 1.2 (Sangue total) Para Autoteste
HANGZHOU ALLTEST BIOTECH CO. LTD
81325990349
May 20, 2024
AUTOTESTE PARA ANTICORPOS DO VÍRUS DE IMUNODEFICIÊNCIA HUMANA (HIV)
Família Teste Rápido HIV 1.2 (Sangue total) Para Autoteste
Not specified
81325990349
May 20, 2024

