220422
IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Antibody
体外诊断 检测试剂/试剂盒、血清学、病毒、丙型肝炎、抗体
Abbott GmbH·D·Hong Kong MDACS·Registered January 03, 2023
Device overview
- Risk class
- D
- Product code
- 17914
- State
- current
- Status
- N/A
- Product code detail
- 17914 IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Antibody
Manufacturer (製造商)
- Name
- Abbott GmbHAbbott Gmbh
- Country
- Germany德国
- Address
- Max-Planck-Ring 2, 65205 Wiesbaden, Germany马克斯-普朗克环 2, 65205 威斯巴登, 德国
Authorised representative (AR)
- Name
- Abbott Laboratories Limited美国雅培制药有限公司
- Phone
- 25668711, 98615786
Regulatory timeline
- Registration date
- January 03, 2023
- Expiry date
- January 03, 2028
Product models
Alinity s Anti-HCV II Calibrator Kit (04W56-02)\r\nAlinity s Anti-HCV II Assay Control Kit (04W56-10)\r\nAlinity s Anti-HCV II Release Control kit (04W56-12)\r\nAlinity s Anti-HCV II Reagent kit (04W56-55) \r\n
Alinity 的 HCV II 抗体校准试剂盒 (04W56-02)\r\nAlinity 的 HCV II 抗体检测控制试剂盒 (04W56-10)\r\nAlinity 的 HCV II 抗体释放控制试剂盒 (04W56-12)\r\nAlinity 的 HCV II 抗体试剂盒 (04W56-55) \r\n
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Antibody. 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 C, Antibody
產品資訊： 体外诊断 检测试剂/试剂盒、血清学、病毒、丙型肝炎、抗体