Pure Global
130371
D
Delisted

IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigenไฝ“ๅค–่ฏŠๆ–ญ่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’๏ผŒ่ก€ๆธ…ๅญฆ๏ผŒ็—…ๆฏ’๏ผŒไน™ๅž‹่‚็‚Ž๏ผŒ่กจ้ขๆŠ—ๅŽŸ

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

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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
17360
State
N/A
Status
Delisted
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Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
United Kingdom
่‹ฑๅ›ฝ
Glyn Phonwy, Llanberis, Gwynedd LL55 4EL, UK
Glyn Phonwy๏ผŒLlanberis๏ผŒGwynedd LL55 4EL๏ผŒUK
Authorised Representative (AR)
Siemens Limited
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25833388
Regulatory Timeline
Registration Date
October 16, 2013
Expiry Date
October 16, 2018
Delist Date
February 17, 2016
Remarks
Delisted.
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Product Models
IMMULITE/ IMMULITE 1000 HBsAg (LKHB1, LKHB5, LSUBX, LPWS2, LKPM)