241044
C
current
IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Tumor Marker, PD-L1ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅ ็ซ็ป่ๅๅญฆ/ๅ ็ซ็ปๅ, ่ฟ็คๆ ๅฟ็ฉ, PD-L1
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
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅ ็ซ็ป่ๅๅญฆ/ๅ ็ซ็ปๅ, ่ฟ็คๆ ๅฟ็ฉ, PD-L1
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
36720
Product Code Detail
36720 IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Tumor Marker, PD-L1
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Roche Diagnostics GmbH
Roche Diagnostics Gmbh
Germany
ๅพทๅฝ
Sandhofer Strasse 116, 68305 Mannheim, Germany
Sandhofer Strasse 116, 68305 ๆผๆตทๅง, ๅพทๅฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
September 24, 2024
Expiry Date
September 23, 2029
Product Models
VENTANA PD-L1 (SP263) Assay (07419821001)
VENTANA PD-L1 (SP263) ๆตๅฎ (07419821001)