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

体外诊断检测试剂/试剂盒, 免疫细胞化学/免疫组化, 肿瘤标志物, PD-L1

Roche Diagnostics GmbH·C·Hong Kong MDACS·Registered September 24, 2024

Device overview

Risk class: C
Product code: 36720
State: current
Status: N/A
Product code detail: 36720 IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Tumor Marker, PD-L1

Manufacturer (製造商)

Name: Roche Diagnostics GmbH
Roche Diagnostics Gmbh
Country: Germany
德国
Address: Sandhofer Strasse 116, 68305 Mannheim, Germany
Sandhofer Strasse 116, 68305 曼海姆, 德国

Authorised representative (AR)

Name: Roche Diagnostics (Hong Kong) Limited
Phone: 24813387

Regulatory timeline

Registration date: September 24, 2024
Expiry date: September 23, 2029

Product models

VENTANA PD-L1 (SP263) Assay (07419821001)

VENTANA PD-L1 (SP263) 测定 (07419821001)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Tumor Marker, PD-L1. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.

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

產品資訊： 体外诊断检测试剂/试剂盒, 免疫细胞化学/免疫组化, 肿瘤标志物, PD-L1