Self-test for human immunodeficiency virus (HIV) antibodies

ANVISA technical name: AUTOTESTE PARA ANTICORPOS DE HIV1/HIV2

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12registrations
12currently valid
10registration holders
11manufacturers
5countries
IVrisk class

Top registration holders

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  • · latest 2022↗ 1
  • · latest 2020↗ 1
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Top manufacturers

  • · Germany↗ 2
  • · United States↗ 1
  • · China↗ 1
  • · France↗ 1
  • · Brazil↗ 1
  • · Brazil↗ 1
  • · Brazil↗ 1
  • · China↗ 1
  • · China↗ 1
  • · United States↗ 1

Countries of manufacture

Related device types

All registrations

ProductClass HolderPublishedStatus
Família Autoteste de HIV Tipos 1 e 2
80113770067
IV ALEXDAN IMPORTAÇÃO E EXPORTAÇÃO LTDA – EPP 21/09/2026 Until 21/09/2036
FaStep HIV Ab Saliva Assure Autoteste
80885650093
IV ORBITAE DIAGNOSTICOS S/A 25/08/2025 Until 25/08/2035
Autoteste de HIV OraQuick®
80430080021
IV CMW SAUDE E TECNOLOGIA IMPORTAÇAO E EXPORTAÇAO LTDA - ME 26/05/2025 Until 26/05/2035
Família Teste Rápido HIV 1.2 (Sangue total) Para Autoteste
81325990349
IV QR CONSULTING, IMPORTACAO E DISTRIBUICAO DE PRODUTOS MEDICOS LTDA 20/05/2024 Until 20/05/2034
Família Autoteste para HIV (Sangue total)
81325990350
IV QR CONSULTING, IMPORTACAO E DISTRIBUICAO DE PRODUTOS MEDICOS LTDA 20/05/2024 Until 20/05/2034
PANBIO HIV SELF TEST
10071770930
IV ABBOTT DIAGNOSTICOS RAPIDOS S.A. 19/09/2022 Until 19/09/2032
CheckNOW HIV SELF TEST
10071770926
IV ABBOTT DIAGNOSTICOS RAPIDOS S.A. 21/03/2022 Until 21/03/2032
AUTOTESTE HIV 1/2 - BIO-MANGUINHOS
80142170054
IV FUNDACAO OSWALDO CRUZ 21/03/2022 Until 21/03/2032
SURE CHECK® HIV ½
80535240060
IV CHEMBIO DIAGNOSTICS BRAZIL LTDA. 17/05/2021 Until 17/05/2031
EXACTO® TEST HIV
80686360310
IV MANDALA BRASIL IMPORTACAO E DISTRIBUICAO DE PRODUTO MEDICO HOSPITALAR LTDA 28/12/2020 Until 28/12/2030
ALERTA
10310030194
IV WAMA PRODUTOS PARA LABORATORIO LTDA 09/04/2018 Until 09/04/2028
Autoteste HIV Detect Oral
80954880049
IV Eco Diagnostica Ltda 18/12/2017 Until 18/12/2027