220142
IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2
体外诊断 检测试剂/试剂盒、血清学、病毒、严重急性呼吸综合征冠状病毒 2
Abbott Ireland Diagnostics Division·C·Hong Kong MDACS·Registered April 29, 2022
Device overview
- Risk class
- C
- Product code
- 41570
- State
- current
- Status
- N/A
- Product code detail
- 41570 IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2
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
- April 29, 2022
- Expiry date
- April 29, 2027
Product models
Alinity i SARS-CoV-2 IgG II Quant Calibrator Kit ((06S61-02)), Alinity i SARS-CoV-2 IgG II Quant Control Kit ((06S61-12)), Alinity i SARS-CoV-2 IgG II Quant Reagent Kit ((06S61-22)), Alinity i SARS-CoV-2 IgG II Quant Reagent Kit ((06S61-32))
铝性 i SARS-CoV-2 IgG II 定量校准试剂盒 ((06S61-02)), 铝性 i SARS-CoV-2 IgG II 定量对照试剂盒 ((06S61-12)), 铝性 i SARS-CoV-2 IgG II 定量试剂盒 ((06S61-22)), 铝性 i SARS-CoV-2 IgG II 定量试剂盒 ((06S61-32))
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2. 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, Severe Acute Respiratory Syndrome Coronavirus 2
產品資訊： 体外诊断 检测试剂/试剂盒、血清学、病毒、严重急性呼吸综合征冠状病毒 2