Applicant profileAbbott Rapid Diagnostics Jena GmbH
Alere Technologies Gmbh
Hong Kong MDACS2 registered devicesJan 20, 2022 – Sep 12, 2023
VerifiedMDD (Medical Device Division) · MDACS registry
2
Total devices
2
Risk classes
2022
First registration
2023
Most recent
Applicant overview
- Applicant (EN)
- Abbott Rapid Diagnostics Jena GmbH
- Applicant (ZH)
- Alere Technologies Gmbh
- Address
- Orlaweg 1, 07743 Jena, GERMANY
Orlaweg 1, 07743 耶拿, 德国
Timeline
- First registration
- Jan 20, 2022
- Most recent
- Sep 12, 2023
Regulatory footprint
Search Abbott Rapid Diagnostics Jena GmbH across other regulatory registries
Thailand
European Union
Colombia
South Korea
Canada
EcuadorRisk class breakdown
C1
D1
Recent MDACS registrations
Latest 15 devices linked to this applicant
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
Sep 12, 2023
- Risk class
- D
- Authorised rep
- Abbott Laboratories Limited美国雅培制药有限公司
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
Jan 20, 2022
- Risk class
- C
- Authorised rep
- Abbott Laboratories Limited美国雅培制药有限公司
About this profile
Abbott Rapid Diagnostics Jena GmbH is associated with 2 medical devices registered under the Hong Kong Medical Device Administrative Control System (MDACS). Explore bilingual product names, risk classes, authorised representatives, and life-cycle milestones.