ANVISA registration

VENTANA PD-L1 (SP263) Assay

Registration 10287411301. COMPANION DIAGNOSTICS

Registration details

Registration number10287411301
Application number25351415911201704
Technical nameCOMPANION DIAGNOSTICS
Risk classIII
Published on14/02/2018
ValidityValid until 14/02/2028

Registration holder

Legal nameROCHE DIAGNÓSTICA BRASIL LTDA
CNPJ30.280.358/0001-86

Manufacturer

  • VENTANA MEDICAL SYSTEM, INC ESTADOS UNIDOS DA AMÉRICA

Other registrations held by ROCHE DIAGNÓSTICA BRASIL LTDAview all

CARDIAC D DIMERO

10287410066

ROCHE AMONIA/ETANOL/CO2 CALIBRATOR

10287410069

CERU, Ceruloplasmina.

10287410074

COBAS INTEGRA FP-CAL (FP CALIBRATION)

10287410075

Família ROCHE AMONIA/ETANOL/ CO2 CONTROLS

10287410079

CARDIAC D DIMERO CONTROLE

10287410080

Source: ANVISA

Source: ANVISA open data, medical device file, updated daily. The public database provides registration validity, rather than registration status: this registration may have been cancelled before its expiry date without this being shown here. Before making purchasing, import or marketing decisions, check the ANVISA search portal.

Next step

Medical device registration with ANVISA

HSC manages the process from risk classification to liaising with the regulator, in Brazil and more than 40 other countries.

Speak to a specialist