FaStep HIV Ab Saliva Assure Autoteste
Self-test for human immunodeficiency virus (HIV) antibodies · class IV · Until 25/08/2035
- Registration no.
- 80885650093
- Process no.
- 25351376489202414
- Status
- Until 25/08/2035
- Device type
- Self-test for human immunodeficiency virus (HIV) antibodies (AUTOTESTE PARA ANTICORPOS DE HIV1/HIV2)
- Risk class
- IV
- Registration holder
- ORBITAE DIAGNOSTICOS S/A CNPJ 11.162.384/0001-65 · 111 registrations
- Manufacturer
- Published
- 25/08/2025
- Valid until
- 25/08/2035
- Last updated by ANVISA
- 2026-10-12
- Official record
- View on ANVISA ↗
Other self-test for human immunodeficiency virus (hiv) antibodies registrations (12 in total, see all)
| Product | Class | Holder | Published | Status |
|---|---|---|---|---|
| Família Autoteste de HIV Tipos 1 e 2
80113770067 |
IV | ALEXDAN IMPORTAÇÃO E EXPORTAÇÃO LTDA – EPP | 21/09/2026 | Until 21/09/2036 |
| 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 |