220415
IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2
体外诊断 检测试剂/试剂盒、血清学、病毒、逆转录病毒、HIV-1/2
Abbott GmbH·D·Hong Kong MDACS·Registered January 03, 2023
Device overview
- Risk class
- D
- Product code
- 19430
- State
- current
- Status
- N/A
- Product code detail
- 19430 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2
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
- January 03, 2023
- Expiry date
- January 03, 2028
Product models
Alinity s HIV Ag/Ab Combo Reagent Kit (06P0155), Alinity s HIV Ag/Ab Combo Calibrator Kit (06P0102), Alinity s HIV Ag/Ab Combo Assay Control Kit (06P0110), Alinity s HIV Ag/Ab Combo Release Control Kit (06P0112)
Alinity s HIV Ag/Ab 组合试剂盒 (06P0155), Alinity s HIV Ag/Ab 组合校准试剂盒 (06P0102), Alinity s HIV Ag/Ab 组合检测试剂盒 (06P0110), Alinity s HIV Ag/Ab 组合释放控制试剂盒 (06P0112)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2. 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, Retrovirus, HIV-1/2
產品資訊： 体外诊断 检测试剂/试剂盒、血清学、病毒、逆转录病毒、HIV-1/2