130369
D
Delisted
IVD Test Reagent/Kits, Serology, Virus, Hepatitis Bไฝๅค่ฏๆญ่ฏๅ/่ฏๅ็๏ผ่กๆธ ๅญฆ๏ผ็ ๆฏ๏ผไนๅ่็
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis B. 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
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
19407
State
N/A
Status
Delisted
ๅทฒ้ๅธ
Manufacturer (่ฃฝ้ ๅ)
Siemens Healthcare Diagnostics Products Limited
Siemens Healthineers
United Kingdom
่ฑๅฝ
Glyn Rhonwy, Llanberis, Gwynedd LL55 4EL, United Kingdom
่ฑๅฝๅจๅฐๅฃซๆ ผๆธฉๅ
ๆฏ๏ผLlanberis๏ผGlyn Rhonwy๏ผ้ฎ็ผ๏ผLL55 4EL
Authorised Representative (AR)
Siemens Healthcare Limited
่ฅฟ้จๅญๅป็ๆ้ๅ
ฌๅธ
25833388
Regulatory Timeline
Registration Date
February 17, 2016
Expiry Date
October 16, 2018
Delist Date
October 26, 2018
Remarks
Delisted.
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Product Models
IMMULITE / IMMULITE 1000 Anti-HBs (LKAH), IMMULITE / IMMULITE 1000 Anti-HBc (LKHC), IMMULITE / IMMULITE 1000 HBsAg (LKHB), IMMULITE / IMMULITE 1000 Anti-HBc IgM (LKMC), IMMULITE / IMMULITE 1000 Chemiluminescent (LSUBX), IMMULITE / IMMULITE 1000 Probe Wash Module (LPWS2), IMMULITE / IMMULITE 1000 Probe Cleaning Kit (LKPM)