220362
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
ARCHITECT STAT High Sensitive Troponin I Calibrators (3P25-02), ARCHITECT STAT High Sensitive Troponin I Controls (3P25-11), ARCHITECT STAT High Sensitive Troponin I Reagent Kit (3P25-26, 3P25-27, 3P25-36, 3P25-37)
建筑师统计高灵敏度肌钙蛋白 I 校准品 (3P25-02), 建筑师统计高灵敏度肌钙蛋白 I 对照 (3P25-11), 建筑师统计高灵敏度肌钙蛋白 I 试剂盒 (3P25-26, 3P25-27, 3P25-36, 3P25-37)
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