HercepTest

Companion diagnostics · class III · Until 27/07/2035

Registration no.
80000230069
Process no.
25351555220201605
Status
Until 27/07/2035
Device type
Companion diagnostics (COMPANION DIAGNOSTICS)
Risk class
III
Registration holder
AGILENT TECHNOLOGIES BRASIL LTDA CNPJ 03.290.250/0001-00 · 84 registrations
Manufacturer
AGILENT TECHNOLOGIES SINGAPORE (INTERNATIONAL) PTE LTD. · Singapore
Published
26/12/2016
Valid until
27/07/2035
Last updated by ANVISA
2026-10-12
Official record
View on ANVISA ↗

Other companion diagnostics registrations (8 in total, see all)

ProductClass HolderPublishedStatus
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
HER2 FISH System
10337990030
III LEICA DO BRASIL IMPORTAÇÃO E COMÉRCIO LTDA. 02/07/2018 Until 23/11/2035
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
Cobas® 4800 BRAF V600 Mutation Test
10287410968
III ROCHE DIAGNÓSTICA BRASIL LTDA 02/01/2012 Until 02/01/2037