240368
B
current
IVD Test Reagent/Kits, Serology, Virus, Hepatitis A, Antibodyไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใ็ฒๅ่็ใๆไฝ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis A, 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 A, Antibody
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใ็ฒๅ่็ใๆไฝ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
17353
Product Code Detail
17353 IVD Test Reagent/Kits, Serology, Virus, Hepatitis A, Antibody
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Siemens Healthcare Diagnostics Inc.
Siemens Healthcare Diagnostics Inc
United States
็พๅฝ
511 Benedict Avenue, Tarrytown, NY 10591, United States
511 Benedict Avenue, ๅก้ๆฆ, NY 10591, ็พๅฝ
Authorised Representative (AR)
Siemens Healthcare Limited
่ฅฟ้จๅญๅป็ๆ้ๅ
ฌๅธ
25833388
Regulatory Timeline
Registration Date
September 11, 2024
Expiry Date
September 10, 2029
Product Models
Atellica IM Hepatitis A Total (aHAVT) (10995446), Atellica IM Hepatitis A Total Quality Control (aHAVT QC) (10995448)
Atellica IM ็ฒๅ่็ๆป้ (aHAVT) (10995446)ใAtellica IM ็ฒๅ่็ๆป่ดจ้ๆงๅถ (aHAVT QC) (10995448)