210446
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Core Antibody
体外诊断 检测试剂/试剂盒、血清学、病毒、乙型肝炎、核心抗体
Siemens Healthcare Diagnostics Products Limited·D·Hong Kong MDACS·Registered January 17, 2022
Device overview
- Risk class
- D
- Product code
- 17355
- State
- current
- Status
- N/A
- Product code detail
- 17355 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Core Antibody
Manufacturer (製造商)
- Name
- Siemens Healthcare Diagnostics Products LimitedSiemens Healthineers
- Country
- United Kingdom英国
- Address
- Glyn Rhonwy, Llanberis, Gwynedd, LL55, 4EL, United KingdomGlyn Rhonwy, Llanberis, Gwynedd, LL55, 4EL, 英国
Authorised representative (AR)
- Name
- Siemens Healthcare Limited西门子医疗有限公司
- Phone
- 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) 质量控制 (10376699)
About this record
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
產品資訊： 体外诊断 检测试剂/试剂盒、血清学、病毒、乙型肝炎、核心抗体