100224
D
Delisted
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antibodyไฝๅค่ฏๆญ่ฏๅ/่ฏๅ็๏ผ่กๆธ ๅญฆ๏ผ็ ๆฏ๏ผไนๅ่็๏ผ่กจ้ขๆไฝ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, 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
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ่ฏๅ/่ฏๅ็๏ผ่กๆธ ๅญฆ๏ผ็ ๆฏ๏ผไนๅ่็๏ผ่กจ้ขๆไฝ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
17359
State
N/A
Status
Delisted
ๅทฒ้ๅธ
Manufacturer (่ฃฝ้ ๅ)
Siemens Healthcare Diagnostics Inc.
Siemens Healthcare Diagnostics Inc
United States
็พๅฝ
511 Benedict Avenue, Tarrytown NY 10591, USA
็พๅฝ็บฝ็บฆๅทๅก้ๆฆ๏ผ่ดๅ
่ฟชๅ
็นๅคง้511ๅท๏ผ้ฎๆฟ็ผ็ 10591
Authorised Representative (AR)
Siemens Limited
่ฅฟ้จๅญๆ้ๅ
ฌๅธ
25833388
Regulatory Timeline
Registration Date
July 08, 2010
Expiry Date
July 08, 2015
Delist Date
February 27, 2015
Remarks
Delisted.
ๅทฒๅพๅ่กจไธญๅช้คใ
Product Models
ADVIA Centaur Anti-HBs (01453163), anti-HBs QC Material (01453546)