210446
D
current
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Core Antibodyไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไนๅ่็ใๆ ธๅฟๆไฝ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Core Antibody. 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, Serology, Virus, Hepatitis B, Core Antibody
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไนๅ่็ใๆ ธๅฟๆไฝ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
17355
Product Code Detail
17355 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Core Antibody
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Siemens Healthcare Diagnostics Products Limited
Siemens Healthineers
United Kingdom
่ฑๅฝ
Glyn Rhonwy, Llanberis, Gwynedd, LL55, 4EL, United Kingdom
Glyn Rhonwy, Llanberis, Gwynedd, LL55, 4EL, ่ฑๅฝ
Authorised Representative (AR)
Siemens Healthcare Limited
่ฅฟ้จๅญๅป็ๆ้ๅ
ฌๅธ
25833388
Regulatory Timeline
Registration Date
January 17, 2022
Expiry Date
January 17, 2027
Product Models
Atellica IM HBc Total 2 (HBcT2) (11200739), Advia Centaur HBc Total 2 (HBcT2) (10376698), Atellica IM HBc Total 2 Quality Control (HBcT2 QC) (11200740), Advia Centaur HBc Total 2 (HBcT2) Quality Control (10376699)
Atellica IM HBc Total 2 (HBcT2) (11200739), Advia Centaur HBc Total 2 (HBcT2) (10376698), Atellica IM HBc Total 2 Quality Control (HBcT2 QC) (11200740), Advia Centaur HBc Total 2 (HBcT2) ่ดจ้ๆงๅถ (10376699)