Pure Global
100359
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

็”ขๅ“่ณ‡่จŠ๏ผš ไฝ“ๅค–่ฏŠๆ–ญ่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’๏ผŒ่ก€ๆธ…ๅญฆ๏ผŒ็—…ๆฏ’๏ผŒไน™ๅž‹่‚็‚Ž๏ผŒ่กจ้ขๆŠ—ไฝ“

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
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DJ Fang

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
United Kingdom
่‹ฑๅ›ฝ
Glyn Rhonwy, Llanberis, Gwynedd LL55 4EL, United Kingdom.
่‹ฑๅ›ฝๅจๅฐ”ๅฃซๅทžๆ ผๆธฉๅ†…ๆ–ฏ้ƒกๅ…ฐไผฏ้‡Œๆ–ฏ้•‡Glyn Rhonwy๏ผŒ้‚ฎๆ”ฟ็ผ–็ LL55 4ELใ€‚
Authorised Representative (AR)
Siemens Healthcare Diagnostics Limited
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25833388
Regulatory Timeline
Registration Date
October 22, 2010
Expiry Date
October 22, 2015
Delist Date
November 12, 2013
Remarks
Delisted.
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Product Models
IMMULITE 2000 Anti-HBs (L2KAH2, L2KAH6, L2SUBM, L2PWSM, L2KPM)