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

Abbott Ireland Diagnostics Division·C·Hong Kong MDACS·Registered August 08, 2024

Device overview

Risk class: C
Product code: 18127
State: current
Status: N/A
Product code detail: 18127 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Prostate Specific Antigen

Manufacturer (製造商)

Name: Abbott Ireland Diagnostics Division
Abbott Ireland Diagnostics Division
Address: Finisklin Business Park, Sligo, IRELAND
菲尼斯克林商业园,爱尔兰斯莱戈

Authorised representative (AR)

Name: Abbott Laboratories Limited
美国雅培制药有限公司
Phone: 25668711, 98615786

Regulatory timeline

Registration date: August 08, 2024
Expiry date: August 07, 2029

Product models

Alinity i Free PSA Reagent Kit (07P9320, 07P9330), Alinity i Free PSA Calibrators (07P9301), Alinity i Free PSA Controls (07P9310)

Alinity i Free PSA 试剂盒 (07P9320, 07P9330), Alinity i Free PSA 校准品 (07P9301), Alinity i Free PSA Controls (07P9310)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Prostate Specific 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, Immunoassay, Tumor Marker, Enzyme, Prostate Specific Antigen

產品資訊： 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