130374
D
Expired.
IVD Test Reagent/Kits, Serology, Virus, Hepatitis Bไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไนๅ่็
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis B. 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
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไนๅ่็
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
19407
Product Code Detail
19407 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B
State
Expired.
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Siemens Healthcare Diagnostics Products Limited
Siemens Healthineers
United Kingdom
่ฑๅฝ
Glyn Rhonwy, Llanberis, Gwynedd LL55 4EL, United Kingdom
ๆ ผๆยทๆๅจ, ๅ
ฐ่ด้ๆฏ, ๆ ผๆธฉๅ
ๆฏ LL55 4EL, ่ฑๅฝ
Authorised Representative (AR)
Siemens Healthcare Limited
่ฅฟ้จๅญๅป็ๆ้ๅ
ฌๅธ
25833388
Regulatory Timeline
Registration Date
October 16, 2018
Expiry Date
October 16, 2023
Product Models
IMMULITE 2000 Anti-HBc IgM (L2KMC), IMMULITE 2000 Anti-HBc (L2KHC), IMMULITE 2000 Anti-HBs (L2KAH), IMMULITE 2000 Chemiluminescent Substrate Module (L2SUBM), IMMULITE 2000 Probe Wash Module (L2PWSM), IMMULITE 2000 Probe Cleaning Kit (L2KPM)
Immulite 2000 ๆ HBc IgM (L2KMC), Immulite 2000 ๆ HBc (L2KHC), Immulite 2000 ๆ HBs (L2KAH), Immulite 2000 ๅๅญฆๅๅ
ๅบ็ฉๆจกๅ (L2SUBM), Immulite 2000 ๆข้ๆธ
ๆดๆจกๅ (L2PWSM), Immulite 2000 ๆข้ๆธ
ๆดๅฅไปถ (L2KPM)