120166
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen, Confirmatory
体外诊断 检测试剂/试剂盒、血清学、病毒、乙型肝炎、表面抗原、确认性
Abbott Ireland, Diagnostic Division·D·Hong Kong MDACS·Registered June 01, 2017
Device overview
- Risk class
- D
- Product code
- 17361
- State
- Expired.
- Status
- N/A
- Product code detail
- 17361 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen, Confirmatory
Manufacturer (製造商)
- Name
- Abbott Ireland, Diagnostic DivisionAbbott
- Country
- Ireland爱尔兰
- Address
- Finisklin Business Park, Sligo, Co.Sligo, Ireland菲尼斯克林商业园,斯莱戈,Co.Sligo,爱尔兰
Authorised representative (AR)
- Name
- Abbott Laboratories Limited美国雅培制药有限公司
- Phone
- 25668711, 98615786
Regulatory timeline
- Registration date
- June 01, 2017
- Expiry date
- June 01, 2022
Product models
ARCHITECT HBsAg Qualitative II Confirmatory assay (2G23-25, 2G23-40)
建筑师 HBsAg 定性 II 确认性测定 (2G23-25, 2G23-40)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen, Confirmatory. 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 Antigen, Confirmatory
產品資訊： 体外诊断 检测试剂/试剂盒、血清学、病毒、乙型肝炎、表面抗原、确认性