240289
C
current
IVD Test Reagent/Kits, Immunoassay, Pregnancy Protein, Alpha-Fetoproteinไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใๅฆๅจ ่็ฝใ็ฒ่่็ฝ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Pregnancy Protein, Alpha-Fetoprotein. 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, Pregnancy Protein, Alpha-Fetoprotein
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
17259
Product Code Detail
17259 IVD Test Reagent/Kits, Immunoassay, Pregnancy Protein, Alpha-Fetoprotein
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Abbott Ireland Diagnostics Division
Abbott Ireland Diagnostics Division
Finisklin Business Park, Sligo, IRELAND
่ฒๅฐผๆฏๅ
ๆๅไธๅญ,็ฑๅฐๅ
ฐๆฏ่ฑๆ
Authorised Representative (AR)
Abbott Laboratories Limited
็พๅฝ้
ๅนๅถ่ฏๆ้ๅ
ฌๅธ
25668711, 98615786
Regulatory Timeline
Registration Date
August 08, 2024
Expiry Date
August 07, 2029
Product Models
Alinity i AFP Reagent Kit (07P9020, 07P9030), Alinity i AFP Calibrators (07P9001), Alinity i AFP Controls (07P9010)
Alinity i AFP ่ฏๅ็ (07P9020ใ07P9030)ใAlinity i AFP ๆ กๅๅ (07P9001)ใAlinity i AFP ๅฏน็
งๅ (07P9010)