Medical Device Division · registration 241044Active

VENTANA PD-L1 (SP263) Assay (07419821001)

Name: VENTANA PD-L1 (SP263) Assay (07419821001) — Medical Device Division 241044
Creator: Roche Diagnostics GmbH
Keywords: VENTANA PD-L1 (SP263) Assay (07419821001), VENTANA PD-L1 (SP263) Assay (07419821001), 241044, IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Tumor Marker, PD-L1, Medical Device Division

Hong KongIVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Tumor Marker, PD-L1IVD Class CRoche Diagnostics GmbH

Verified

Official record identity

MDACS listing number: 241044
Model name: VENTANA PD-L1 (SP263) Assay (07419821001)
Registration date: January 03, 2025
Expiry date: September 23, 2029
Source update date: February 12, 2025
Status: Active

Classification

Risk class: IVD Class C
Published category: IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Tumor Marker, PD-L1

Published parties

Registrant / registration holder: Roche Diagnostics (Hong Kong) Limited
Manufacturer: Roche Diagnostics GmbH

Official description

IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Tumor Marker, PD-L1

Additional source fields

AMD nomenclature code: 36720
Traditional Chinese local responsible person: 羅氏診斷(香港)有限公司
Local responsible person phone: 24813387
Published manufacturer address: Sandhofer Strasse 116, 68305 Mannheim, Germany
Revision number: a

About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.