240201
IVD Test Reagent/Kits, Immunoassay, Brain Trauma
体外诊断检测试剂/试剂盒、免疫测定、脑外伤
Abbott Ireland Diagnostics Division·C·Hong Kong MDACS·Registered June 04, 2024
Device overview
- Risk class
- C
- Product code
- 40103
- State
- current
- Status
- N/A
- Product code detail
- 40103 IVD Test Reagent/Kits, Immunoassay, Brain Trauma
Manufacturer (製造商)
- Name
- Abbott Ireland Diagnostics DivisionAbbott Ireland Diagnostics Division
- 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
- June 04, 2024
- Expiry date
- June 03, 2029
Product models
GFAP Reagent Kit (4W16-25), GFAP Calibrators (4W16-01), GFAP Controls (4W16-10), UCH-L1 Reagent Kit (4W18-25), UCH-L1 Calibrators (4W18-01), UCH-L1 Controls (4W18-10), TBI (04Z22)
GFAP 试剂盒 (4W16-25)、GFAP 校准品 (4W16-01)、GFAP 质控品 (4W16-10)、UCH-L1 试剂盒 (4W18-25)、UCH-L1 质试剂盒 (4W18-01)、UCH-L1 质控品 (4W18-10)、TBI (04Z22)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Brain Trauma. 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, Immunoassay, Brain Trauma
產品資訊： 体外诊断检测试剂/试剂盒、免疫测定、脑外伤