190030
D
Expired.
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antibodyไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไนๅ่็ใ่กจ้ขๆไฝ
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 ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไนๅ่็ใ่กจ้ขๆไฝ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
17359
Product Code Detail
17359 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antibody
State
Expired.
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Siemens Healthcare Diagnostics Inc
Siemens Healthcare Diagnostics Inc
United States
็พๅฝ
511 Benedict Avenue, Tarrytown, New York 10591, USA
511 Benedict Avenue, Tarrytown, New York 10591, USA
Authorised Representative (AR)
Siemens Healthcare Limited
่ฅฟ้จๅญๅป็ๆ้ๅ
ฌๅธ
25833388
Regulatory Timeline
Registration Date
January 24, 2019
Expiry Date
January 24, 2024
Product Models
Atellica IM Anti-Hepatitis B surface Antigen 2 (10995453), Atellica IM Anti-Hepatitis B surface Antigen 2 Quality Control (10995454)
Atellica IM ๆไนๅ่็่กจ้ขๆๅ 2 (10995453)ใAtellica IM ๆไนๅ่็่กจ้ขๆๅ 2 ่ดจ้ๆงๅถ (10995454)