180536
D
Expired.
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, IgM Core Antibodyไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไนๅ่็ใIgM ๆ ธๅฟๆไฝ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, 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
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไนๅ่็ใIgM ๆ ธๅฟๆไฝ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
17356
Product Code Detail
17356 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, IgM Core 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
December 18, 2018
Expiry Date
December 18, 2023
Product Models
Atellica IM Hepatitis B Core Antigen (10995449), Atellica IM Hepatitis B Core Antigen Quality Control (10995450)
Atellica IM ไนๅ่็ๆ ธๅฟๆๅ (10995449)ใAtellica IM ไนๅ่็ๆ ธๅฟๆๅ่ดจ้ๆงๅถ (10995450)