240370
IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyrotropin
体外诊断 测试试剂/试剂盒、免疫测定、甲状腺激素、促甲状腺素
Abbott Ireland Diagnostics Division·B·Hong Kong MDACS·Registered September 11, 2024
Device overview
- Risk class
- B
- Product code
- 19865
- State
- current
- Status
- N/A
- Product code detail
- 19865 IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyrotropin
Manufacturer (製造商)
- Name
- Abbott Ireland Diagnostics DivisionAbbott Ireland Diagnostics Division
- Address
- Lisnamuck, Longford, Co. Longford, IRELANDLisnamuck, Longford, Co. 朗福德, 爱尔兰
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 11, 2024
- Expiry date
- September 10, 2029
Product models
Alinity i TSH Reagent Kit (07P4820, 07P4830), Alinity i TSH Calibrators (07P4801), Alinity i TSH Controls (07P4810)
Alinity i TSH 试剂盒(07P4820、07P4830)、Alinity i TSH 校准品 (07P4801)、Alinity i TSH 质控品 (07P4810)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyrotropin. 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, Immunoassay, Thyroid Hormone, Thyrotropin
產品資訊： 体外诊断 测试试剂/试剂盒、免疫测定、甲状腺激素、促甲状腺素