190030
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antibody
体外诊断 检测试剂/试剂盒、血清学、病毒、乙型肝炎、表面抗体
Siemens Healthcare Diagnostics Inc·D·Hong Kong MDACS·Registered January 24, 2019
Device overview
- Risk class
- D
- Product code
- 17359
- State
- Expired.
- Status
- N/A
- Product code detail
- 17359 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antibody
Manufacturer (製造商)
- Name
- Siemens Healthcare Diagnostics IncSiemens Healthcare Diagnostics Inc
- Country
- United States美国
- Address
- 511 Benedict Avenue, Tarrytown, New York 10591, USA511 Benedict Avenue, Tarrytown, New York 10591, USA
Authorised representative (AR)
- Name
- Siemens Healthcare Limited西门子医疗有限公司
- Phone
- 25833388
Regulatory timeline
- Registration date
- January 24, 2019
- Expiry date
- January 24, 2024
Product models
Atellica IM Anti-Hepatitis B surface Antigen 2 (10995453), Atellica IM Anti-Hepatitis B surface Antigen 2 Quality Control (10995454)
Atellica IM 抗乙型肝炎表面抗原 2 (10995453)、Atellica IM 抗乙型肝炎表面抗原 2 质量控制 (10995454)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface 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, Surface 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、表面抗体