190362
D
current
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigenไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไนๅ่็ใ่กจ้ขๆๅ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface 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, Serology, Virus, Hepatitis B, Surface Antigen
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไนๅ่็ใ่กจ้ขๆๅ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
17360
Product Code Detail
17360 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Abbott Ireland Diagnostics Division
Abbott Ireland Diagnostics Division
Ireland
็ฑๅฐๅ
ฐ
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
November 04, 2029
Product Models
Alinity i HBsAg Reagent Kit (08P0822, 08P0832, 08P0852, 08P0857), Alinity i HBsAg Calibrators (08P0801), Alinity i HBsAg Controls (08P0810), Alinity i HBsAg Manual Diluent (08P0843)
Alinity i HBsAg ่ฏๅ็(08P0822ใ08P0832ใ08P0852ใ08P0857)ใAlinity i HBsAg ๆ กๅๅ (08P0801)ใAlinity i HBsAg ่ดจๆงๅ (08P0810)ใAlinity i HBsAg ๆๅจ็จ้ๅ (08P0843)