120506
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen
体外诊断 检测试剂/试剂盒、血清学、病毒、乙型肝炎、表面抗原
Abbott Ireland Diagnostics Division·D·Hong Kong MDACS·Registered January 04, 2023
Device overview
- Risk class
- D
- Product code
- 17360
- State
- current
- Status
- N/A
- Product code detail
- 17360 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen
Manufacturer (製造商)
- Name
- Abbott Ireland Diagnostics DivisionAbbott Ireland Diagnostics Division
- Country
- Ireland爱尔兰
- Address
- Finisklin Business Park, Sligo, Co Sligo, Ireland菲尼斯克林商业园,斯莱戈,科斯莱戈,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
- January 04, 2023
- Expiry date
- March 01, 2028
Product models
ARCHITECT HBsAg Reagent Kit (6C36-41, 6C36-42), ARCHITECT HBsAg Calibrators (3M61-01), ARCHITECT HBsAg Controls (6C36-10)
建筑师 HBsAg 试剂盒 (6C36-41, 6C36-42), 建筑师 HBsAg 校准器 (3M61-01), 建筑师 HBsAg 对照 (6C36-10)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen. 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
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