HER2 FISH System
Companion diagnostics · class III · Until 23/11/2035
- Registration no.
- 10337990030
- Process no.
- 25351093017201881
- Status
- Until 23/11/2035
- Device type
- Companion diagnostics (COMPANION DIAGNOSTICS)
- Risk class
- III
- Registration holder
- LEICA DO BRASIL IMPORTAÇÃO E COMÉRCIO LTDA. CNPJ 52.201.456/0001-13 · 90 registrations
- Manufacturer
- Published
- 02/07/2018
- Valid until
- 23/11/2035
- Last updated by ANVISA
- 2026-10-12
- Official record
- View on ANVISA ↗
Other companion diagnostics registrations (8 in total, see all)
| Product | Class | Holder | Published | Status |
|---|---|---|---|---|
| Anti-ALK (D5F3) Rabbit Monoclonal Primary
10287411745 |
III | ROCHE DIAGNÓSTICA BRASIL LTDA | 05/05/2025 | Until 05/05/2035 |
| VENTANA FOLR1 (FOLR-2.1) RxDx Assay
10287411743 |
III | ROCHE DIAGNÓSTICA BRASIL LTDA | 07/04/2025 | Until 07/04/2035 |
| VENTANA PD-L1 (SP263) Assay
10287411301 |
III | ROCHE DIAGNÓSTICA BRASIL LTDA | 14/02/2018 | Until 14/02/2028 |
| FAMÍLIA MARCADOR TUMORAL PD-L1
80000230077 |
III | AGILENT TECHNOLOGIES BRASIL LTDA | 03/04/2017 | Until 19/12/2036 |
| VENTANA PD-L1 (SP142) Assay
10287411206 |
III | ROCHE DIAGNÓSTICA BRASIL LTDA | 13/03/2017 | Until 13/03/2037 |
| HercepTest
80000230069 |
III | AGILENT TECHNOLOGIES BRASIL LTDA | 26/12/2016 | Until 27/07/2035 |
| Cobas® 4800 BRAF V600 Mutation Test
10287410968 |
III | ROCHE DIAGNÓSTICA BRASIL LTDA | 02/01/2012 | Until 02/01/2037 |