230295
IVD Test Reagent/Kits, Serology, Rapid Test, Virus, Retrovirus, HIV-1/2
体外诊断 检测试剂/试剂盒、血清学、快速检测、病毒、逆转录病毒、HIV-1/2
Abbott Rapid Diagnostics Jena GmbH·D·Hong Kong MDACS·Registered September 12, 2023
Device overview
- Risk class
- D
- Product code
- 19478
- State
- current
- Status
- N/A
- Product code detail
- 19478 IVD Test Reagent/Kits, Serology, Rapid Test, Virus, Retrovirus, HIV-1/2
Manufacturer (製造商)
- Name
- Abbott Rapid Diagnostics Jena GmbHAlere Technologies Gmbh
- Address
- Orlaweg 1, 07743 Jena, GERMANYOrlaweg 1, 07743 耶拿, 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
- September 12, 2023
- Expiry date
- September 12, 2028
Product models
Panbio HIV Self Test (29012M001)
泛生物艾滋病毒自我检测 (29012M001)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Rapid Test, 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, Rapid Test, Virus, Retrovirus, HIV-1/2
產品資訊： 体外诊断 检测试剂/试剂盒、血清学、快速检测、病毒、逆转录病毒、HIV-1/2