230016
D
current
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antibodyไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไนๅ่็ใ่กจ้ขๆไฝ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antibody. 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 Antibody
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไนๅ่็ใ่กจ้ขๆไฝ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
17359
Product Code Detail
17359 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antibody
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
January 19, 2023
Expiry Date
January 19, 2028
Product Models
ARCHITECT Anti-HBs Reagent Kit (7C18-29, 7C18-33, 7C18-39, 7C18-41, 7C18-42), ARCHITECT Anti-HBs Calibrators (7C18-03), ARCHITECT Anti-HBs Controls (7C18-13), ARCHITECT Anti-HBs Specimen Diluent (7C18-40)
ๅปบ็ญๅธๆ-HBs่ฏๅ็(7C18-29,7C18-33,7C18-39,7C18-41,7C18-42),ๅปบ็ญๅธๆHBsๆ กๅๅ(7C18-03),ๅปบ็ญๅธๆHBsๅฏน็
ง(7C18-13),ๅปบ็ญๅธๆHBsๆ ทๆฌ็จ้ๅ(7C18-40)