120506
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, Co Sligo, Ireland
่ฒๅฐผๆฏๅ
ๆๅไธๅญ,ๆฏ่ฑๆ,็งๆฏ่ฑๆ,็ฑๅฐๅ
ฐ
Authorised Representative (AR)
Abbott Laboratories Limited
็พๅฝ้
ๅนๅถ่ฏๆ้ๅ
ฌๅธ
25668711, 98615786
Regulatory Timeline
Registration Date
January 04, 2023
Expiry Date
March 01, 2028
Product Models
ARCHITECT HBsAg Reagent Kit (6C36-41, 6C36-42), ARCHITECT HBsAg Calibrators (3M61-01), ARCHITECT HBsAg Controls (6C36-10)
ๅปบ็ญๅธ HBsAg ่ฏๅ็ (6C36-41, 6C36-42), ๅปบ็ญๅธ HBsAg ๆ กๅๅจ (3M61-01), ๅปบ็ญๅธ HBsAg ๅฏน็
ง (6C36-10)