Pure Global
100426
D
Delisted

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

This profile provides complete Hong Kong MDACS registration information for Reagents, 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 ไฝ“ๅค–่ฏŠๆ–ญ่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’๏ผŒ่ก€ๆธ…ๅญฆ๏ผŒ็—…ๆฏ’๏ผŒไน™ๅž‹่‚็‚Ž๏ผŒIgMๆ ธๅฟƒๆŠ—ไฝ“

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
17356
State
N/A
Status
Delisted
ๅทฒ้€€ๅธ‚
Pure Global
DJ Fang

DJ Fang

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
United Kingdom
่‹ฑๅ›ฝ
Glyn Rhonwy, Llanberis, Gwynedd LL55 4EL, UK
่‹ฑๅ›ฝๅจๅฐ”ๅฃซๅทžๆ ผๆธฉๅ†…ๆ–ฏ้ƒกๅ…ฐไผฏ้‡Œๆ–ฏ๏ผŒGlyn Rhonwy๏ผŒ้‚ฎๆ”ฟ็ผ–็ LL55 4EL
Authorised Representative (AR)
Siemens Healthcare Diagnostics Limited
่ฅฟ้—จๅญๅŒป็–—่ฏŠๆ–ญ่ฎพๅค‡ๆœ‰้™ๅ…ฌๅธ
25833388
Regulatory Timeline
Registration Date
November 26, 2010
Expiry Date
November 26, 2015
Delist Date
November 12, 2013
Remarks
Delisted.
ๅทฒๅพžๅˆ—่กจไธญๅˆช้™คใ€‚
Product Models
Immulite 2000 Anti-HBc IgM Assay (L2KMC2, L2KMC6, L2SUBM, L2PWSM, L2KPM)