190029
D
Expired.
IVD Test Reagent/Kits, Serology, Virus, Hepatitis Be, Antigenไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไนๅ่็ใๆๅ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis Be, Antigen. 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 Be, Antigen
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไนๅ่็ใๆๅ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
19060
Product Code Detail
19060 IVD Test Reagent/Kits, Serology, Virus, Hepatitis Be, Antigen
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 Hepatitis B e Antigen (10995600), Atellica IM Hepatitis B e Antigen Quality Control (10995601)
Atellica IM ไนๅ่็ e ๆๅ (10995600), Atellica IM ไนๅ่็ e ๆๅ่ดจ้ๆงๅถ (10995601)