PSA FIA Assure Test
Prostate-specific antigen (PSA) · class III · Until 21/09/2036
- Registration no.
- 80885650110
- Process no.
- 25351119575202693
- Status
- Until 21/09/2036
- Device type
- Prostate-specific antigen (PSA) (ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA))
- Risk class
- III
- Registration holder
- ORBITAE DIAGNOSTICOS S/A CNPJ 11.162.384/0001-65 · 111 registrations
- Manufacturer
- Published
- 21/09/2026
- Valid until
- 21/09/2036
- Last updated by ANVISA
- 2026-10-12
- Official record
- View on ANVISA ↗
Other prostate-specific antigen (psa) registrations (71 in total, see all)
| Product | Class | Holder | Published | Status |
|---|---|---|---|---|
| BIOCLIN POCT FIA PSA TOTAL
10269360504 |
III | QUIBASA - QUIMICA BASICA LTDA | 27/07/2026 | Until 27/07/2036 |
| Atellica IM total PSA II (tPSAII)
10345162561 |
III | SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA | 04/05/2026 | Until 04/05/2036 |
| Família VITROS Immunodiagnostic Products Total PSA II Reagent Pack and Calibrator
81246986919 |
III | ORTHO CLINICAL DIAGNÓSTICS DO BRASIL PRODUTOS PARA SAÚDE LTDA | 22/04/2026 | Until 22/04/2036 |
| PSA Total Test System - ELISA
80048490106 |
III | USA DIAGNOSTICA LTDA | 05/01/2026 | Until 05/01/2036 |
| Família PSA Quantitative Test Kit (Time-Resolved FIA)
82444370307 |
III | Enzytec Biotecnologia Ltda. | 29/12/2025 | Until 29/12/2035 |
| FASTLINE PSA QUALITATIVO
80105220290 |
III | KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA | 01/12/2025 | Until 01/12/2035 |
| PSA
82533950127 |
III | MR SAUDE LTDA | 10/11/2025 | Until 10/11/2035 |
| Total PSA Chemiluminescent Immunoassay Kit
82444370287 |
III | Enzytec Biotecnologia Ltda. | 13/10/2025 | Until 13/10/2035 |