100276
D
Delisted
Reagents, Serology, Virus, Hepatitis B, Surface Antibody่ฏๅใ่กๆธ ๅญฆใ็ ๆฏใไนๅ่็ใ่กจ้ขๆไฝ
This profile provides complete Hong Kong MDACS registration information for Reagents, 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 ไฝๅค่ฏๆญ่ฏๅ/่ฏๅ็๏ผ่กๆธ ๅญฆ๏ผ็ ๆฏ๏ผไนๅ่็๏ผ่กจ้ขๆไฝ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
17359
State
N/A
Status
Delisted
ๅทฒ้ๅธ
Manufacturer (่ฃฝ้ ๅ)
Siemens Healthcare Diagnostics Products Limited
Siemens Healthineers
United Kingdom
่ฑๅฝ
Glyn Phonwy, Llanberis, Gwynedd LL55 4EL, UK
่ฑๅฝๅจๅฐๅฃซๆ ผๆธฉๅ
ๆฏ้กๅ
ฐไผฏ้ๆฏ๏ผGlyn Phonwy๏ผ้ฎๆฟ็ผ็ LL55 4EL
Authorised Representative (AR)
Siemens Healthcare Diagnostics Limited
่ฅฟ้จๅญๅป็่ฏๆญ่ฎพๅคๆ้ๅ
ฌๅธ
25833388
Regulatory Timeline
Registration Date
August 06, 2010
Expiry Date
August 06, 2015
Delist Date
November 12, 2013
Remarks
Delisted.
ๅทฒๅพๅ่กจไธญๅช้คใ
Product Models
Immulite / Immulite 1000 Anti-HBs Assay (LKAH1, LKAH5, LSUBX, LPWS2, LKPM)

