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Applicant profile

Abbott Ireland Diagnostics Division

Abbott Ireland Diagnostics Division
Hong Kong MDACS17 registered devicesApr 23, 2015 – Sep 11, 2024
VerifiedMDD (Medical Device Division) · MDACS registry
17
Total devices
3
Risk classes
2015
First registration
2024
Most recent
Applicant overview
Applicant (EN)
Abbott Ireland Diagnostics Division
Applicant (ZH)
Abbott Ireland Diagnostics Division
Address
Lisnamuck, Longford, Co. Longford, IRELAND
Lisnamuck, Longford, Co. 朗福德, 爱尔兰
Timeline
First registration
Apr 23, 2015
Most recent
Sep 11, 2024
Regulatory footprint
Search Abbott Ireland Diagnostics Division across other regulatory registries
ThailandEuropean UnionColombiaSouth KoreaCanadaEcuador
Risk class breakdown
B2
C7
D8
Recent MDACS registrations
Latest 15 devices linked to this applicant
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
Sep 11, 2024
Risk class
B
Authorised rep
Abbott Laboratories Limited美国雅培制药有限公司
IVD Test Reagent/Kits, Immunoassay, Pregnancy Protein, Alpha-Fetoprotein
体外诊断 测试试剂/试剂盒、免疫测定、妊娠蛋白、甲胎蛋白
Aug 08, 2024
Risk class
C
Authorised rep
Abbott Laboratories Limited美国雅培制药有限公司
IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Oncofetal, Carcinoembryonic Antigen
体外诊断 检测试剂/试剂盒、免疫测定、肿瘤标志物、肿瘤胎儿、癌胚抗原
Aug 08, 2024
Risk class
C
Authorised rep
Abbott Laboratories Limited美国雅培制药有限公司
IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Prostate Specific Antigen
体外诊断 检测试剂/试剂盒、免疫测定、肿瘤标志物、酶、前列腺特异性抗原
Aug 08, 2024
Risk class
C
Authorised rep
Abbott Laboratories Limited美国雅培制药有限公司
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
Aug 08, 2024
Risk class
B
Authorised rep
Abbott Laboratories Limited美国雅培制药有限公司
IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Prostate Specific Antigen
体外诊断 检测试剂/试剂盒、免疫测定、肿瘤标志物、酶、前列腺特异性抗原
Aug 08, 2024
Risk class
C
Authorised rep
Abbott Laboratories Limited美国雅培制药有限公司
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antibody
体外诊断 检测试剂/试剂盒、血清学、病毒、乙型肝炎、表面抗体
Aug 08, 2024
Risk class
D
Authorised rep
Abbott Laboratories Limited美国雅培制药有限公司
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen
体外诊断 检测试剂/试剂盒、血清学、病毒、乙型肝炎、表面抗原
Aug 08, 2024
Risk class
D
Authorised rep
Abbott Laboratories Limited美国雅培制药有限公司
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen
体外诊断 检测试剂/试剂盒、血清学、病毒、乙型肝炎、表面抗原
Jul 24, 2024
Risk class
D
Authorised rep
Abbott Laboratories Limited美国雅培制药有限公司
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen, Confirmatory
体外诊断 检测试剂/试剂盒、血清学、病毒、乙型肝炎、表面抗原、确认性
Jul 24, 2024
Risk class
D
Authorised rep
Abbott Laboratories Limited美国雅培制药有限公司
IVD Test Reagent/Kits, Immunoassay, Brain Trauma
体外诊断检测试剂/试剂盒、免疫测定、脑外伤
Jun 04, 2024
Risk class
C
Authorised rep
Abbott Laboratories Limited美国雅培制药有限公司
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antibody
体外诊断 检测试剂/试剂盒、血清学、病毒、乙型肝炎、表面抗体
Jan 19, 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, Hepatitis B, Surface Antigen
体外诊断 检测试剂/试剂盒、血清学、病毒、乙型肝炎、表面抗原
Jan 04, 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
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
Apr 29, 2022
Risk class
C
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
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
Apr 29, 2022
Risk class
C
Authorised rep
Abbott Laboratories Limited美国雅培制药有限公司
View all 17 devices →
About this profile

Abbott Ireland Diagnostics Division is associated with 17 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.