220019
IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antigen
体外诊断 检测试剂/试剂盒、血清学、病毒、严重急性呼吸综合征冠状病毒2、抗原
Abbott Rapid Diagnostics Jena GmbH·C·Hong Kong MDACS·Registered January 20, 2022
Device overview
- Risk class
- C
- Product code
- 41618
- State
- current
- Status
- N/A
- Product code detail
- 41618 IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antigen
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
- January 20, 2022
- Expiry date
- January 20, 2027
Product models
Panbio COVID-19 Antigen Self-Test (41FK51, 41FK71, 41FK81, 41FK91)
泛生物 COVID-19 抗原自检(41FK51、41FK71、41FK81、41FK91)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, 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, Severe Acute Respiratory Syndrome Coronavirus 2, Antigen
產品資訊： 体外诊断 检测试剂/试剂盒、血清学、病毒、严重急性呼吸综合征冠状病毒2、抗原