220361
IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Troponin-I
体外诊断 测试试剂/试剂盒、免疫测定、心脏标志物、蛋白质、肌钙蛋白-I
Abbott Ireland, Diagnostics Division·C·Hong Kong MDACS·Registered November 03, 2022
Device overview
- Risk class
- C
- Product code
- 19689
- State
- current
- Status
- N/A
- Product code detail
- 19689 IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Troponin I
Manufacturer (製造商)
- Name
- Abbott Ireland, Diagnostics DivisionAbbott Ireland Diagnostics Division
- Country
- Ireland爱尔兰
- Address
- Lisnamuck, Longford, Co. Longford, Ireland利斯纳穆克,朗福德,公司 朗福德,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
- November 03, 2022
- Expiry date
- November 03, 2027
Product models
Alinity i STAT High Sensitive Troponin-I Calibrators (08P13-01), Alinity i STAT High Sensitive Troponin-I Controls (08P13-10), Alinity i STAT High Sensitive Troponin-I Reagent Kit (08P13-22, 08P13-24, 08P13-27, 08P13-32, 08P13-34, 08P13-37)
Alinity i STAT 高灵敏度肌钙蛋白-I 校准品 (08P13-01), Alinity i STAT 高灵敏度肌钙蛋白-I 对照 (08P13-10), Alinity i STAT 高灵敏度肌钙蛋白-I 试剂盒 (08P13-22, 08P13-24, 08P13-27, 08P13-32, 08P13-34, 08P13-37)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Troponin-I. 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, Cardiac Marker, Protein, Troponin I
產品資訊： 体外诊断 测试试剂/试剂盒、免疫测定、心脏标志物、蛋白质、肌钙蛋白 I