140349
IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Core Antigen
体外诊断 检测试剂/试剂盒、血清学、病毒、丙型肝炎、核心抗原
Abbott GmbH & Co. KG·D·Hong Kong MDACS·Registered July 24, 2024
Device overview
- Risk class
- D
- Product code
- 19062
- State
- current
- Status
- N/A
- Product code detail
- 19062 IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Core Antigen
Manufacturer (製造商)
- Name
- Abbott GmbH & Co. KGAbbott 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
- July 24, 2024
- Expiry date
- October 16, 2029
Product models
ARCHITECT HCV Ag Reagent Kit (6L47-27), ARCHITECT HCV Ag Calibrators (6L47-02), ARCHITECT HCV Ag Controls (6L47-11)
建筑师HCV农业试剂盒(6L47-27),建筑师HCV农业校准器(6L47-02),建筑师HCV农业对照(6L47-11)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Core Antigen. 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, Core Antigen
產品資訊： 体外诊断 检测试剂/试剂盒、血清学、病毒、丙型肝炎、核心抗原