Pure Global
130372
D
Delisted

IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, IgM Core AntibodyIVD ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’๏ผŒ่ก€ๆธ…ๅญฆ๏ผŒ็—…ๆฏ’๏ผŒไน™ๅž‹่‚็‚Ž๏ผŒIgM ๆ ธๅฟƒๆŠ—ไฝ“

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, IgM Core 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, IgM Core Antibody

็”ขๅ“่ณ‡่จŠ๏ผš IVD ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’๏ผŒ่ก€ๆธ…ๅญฆ๏ผŒ็—…ๆฏ’๏ผŒไน™ๅž‹่‚็‚Ž๏ผŒIgM ๆ ธๅฟƒๆŠ—ไฝ“

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
17356
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 Rhonwy, Llanberis, Gwynedd LL55 4EL, UK
่‹ฑๅ›ฝๅจๅฐ”ๅฃซๆ ผๆธฉๅ†…ๆ–ฏ๏ผŒLlanberis๏ผŒGlyn Rhonwy๏ผŒ้‚ฎ็ผ–๏ผšLL55 4EL
Authorised Representative (AR)
Siemens Limited
่ฅฟ้—จๅญๆœ‰้™ๅ…ฌๅธ
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 Anti-HBc IgM (LKMC1, LKMC5, L1KMCW, LSUBX, LPWS2, LKPM)