190373
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 Diagnostics Division·D·Hong Kong MDACS·Registered July 24, 2024
Device overview
- Risk class
- D
- Product code
- 17361
- State
- current
- 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 Diagnostics DivisionAbbott Ireland Diagnostics Division
- Country
- Ireland爱尔兰
- Address
- Finisklin Business Park, Sligo, Ireland菲尼斯克林商业园,爱尔兰斯莱戈
Authorised representative (AR)
- Name
- Abbott Laboratories Limited美国雅培制药有限公司
- Phone
- 25668711, 98615786
Regulatory timeline
- Registration date
- July 24, 2024
- Expiry date
- November 25, 2029
Product models
Alinity i HBsAg Qualitative II Calibrators (08P1001), Alinity i HBsAg Qualitative II Controls (08P1010), Alinity i HBsAg Qualitative II Confirmatory Reagent Kit (08P1122), Alinity i HBsAg Qualitative II Confirmatory Manual Diluent (08P1140)
Alinity i HBsAg 定性 II 校准品 (08P1001), Alinity i HBsAg 定性 II 质控品 (08P1010), Alinity i HBsAg 定性 II 验证试剂盒 (08P1122), Alinity i HBsAg 定性 II 确认性手动稀释剂 (08P1140)
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