240338
C
current
IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Prostate Specific Antigenไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ่ฟ็คๆ ๅฟ็ฉใ้ ถใๅๅ่ บ็นๅผๆงๆๅ
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
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ่ฟ็คๆ ๅฟ็ฉใ้ ถใๅๅ่ บ็นๅผๆงๆๅ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
18127
Product Code Detail
18127 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Prostate Specific Antigen
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 Free PSA Reagent Kit (07P9320, 07P9330), Alinity i Free PSA Calibrators (07P9301), Alinity i Free PSA Controls (07P9310)
Alinity i Free PSA ่ฏๅ็ (07P9320, 07P9330), Alinity i Free PSA ๆ กๅๅ (07P9301), Alinity i Free PSA Controls (07P9310)