Pure Global
100276
D
Delisted

Reagents, Serology, Virus, Hepatitis B, Surface Antibody่ฏ•ๅ‰‚ใ€่ก€ๆธ…ๅญฆใ€็—…ๆฏ’ใ€ไน™ๅž‹่‚็‚Žใ€่กจ้ขๆŠ—ไฝ“

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

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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
17359
State
N/A
Status
Delisted
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Pure Global
DJ Fang

DJ Fang

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
United Kingdom
่‹ฑๅ›ฝ
Glyn Phonwy, Llanberis, Gwynedd LL55 4EL, UK
่‹ฑๅ›ฝๅจๅฐ”ๅฃซๆ ผๆธฉๅ†…ๆ–ฏ้ƒกๅ…ฐไผฏ้‡Œๆ–ฏ๏ผŒGlyn Phonwy๏ผŒ้‚ฎๆ”ฟ็ผ–็ LL55 4EL
Authorised Representative (AR)
Siemens Healthcare Diagnostics Limited
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25833388
Regulatory Timeline
Registration Date
August 06, 2010
Expiry Date
August 06, 2015
Delist Date
November 12, 2013
Remarks
Delisted.
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Product Models
Immulite / Immulite 1000 Anti-HBs Assay (LKAH1, LKAH5, LSUBX, LPWS2, LKPM)