240062
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, IgM Core Antibody
体外诊断 检测试剂/试剂盒、血清学、病毒、乙型肝炎、IgM 核心抗体
Abbott GmbH·D·Hong Kong MDACS·Registered February 19, 2024
Device overview
- Risk class
- D
- Product code
- 17356
- State
- current
- Status
- N/A
- Product code detail
- 17356 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, IgM Core Antibody
Manufacturer (製造商)
- Name
- Abbott GmbHAbbott Gmbh
- 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
- February 19, 2024
- Expiry date
- February 18, 2029
Product models
ARCHITECT Anti-HBc IgM Calibrators (6C33-02), ARCHITECT Anti-HBc IgM Controls (6C33-11), ARCHITECT Anti-HBc IgM Reagent Kit (6C33-22, 6C33-27)
ARCHITECT 抗 HBc IgM 校准品 (6C33-02), ARCHITECT 抗 HBc IgM 对照品 (6C33-11), ARCHITECT 抗 HBc IgM 试剂盒 (6C33-22, 6C33-27)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, IgM Core 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 B, IgM Core Antibody
產品資訊： 体外诊断 检测试剂/试剂盒、血清学、病毒、乙型肝炎、IgM 核心抗体