220280
B
current
IVD Test Reagent/Kits, Immunoassay, Autoimmune, Thyroid, Thyroglobulin Antibodyไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ่ช่บซๅ ็ซใ็ฒ็ถ่ บใ็ฒ็ถ่ บ็่็ฝๆไฝ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Autoimmune, Thyroid, Thyroglobulin 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, Immunoassay, Autoimmune, Thyroid, Thyroglobulin Antibody
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ่ช่บซๅ ็ซใ็ฒ็ถ่ บใ็ฒ็ถ่ บ็่็ฝๆไฝ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
17280
Product Code Detail
17280 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Thyroid, Thyroglobulin Antibody
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Siemens Healthcare Diagnostics Products Limited
Siemens Healthineers
United Kingdom
่ฑๅฝ
Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL, United Kingdom
Glyn Rhonwy, ๅ
ฐ่ด้ๆฏ, ๆ ผๆธฉๅ
ๆฏ, LL55 4EL, ่ฑๅฝ
Authorised Representative (AR)
Siemens Healthcare Limited
่ฅฟ้จๅญๅป็ๆ้ๅ
ฌๅธ
25833388
Regulatory Timeline
Registration Date
September 20, 2022
Expiry Date
September 20, 2027
Product Models
Atellica IM Anti-Thyroglobulin II(aTgII) (11201759, 11201761), Atellica aTgII Quality Control (aTgII QC) (11201752), Atellica aTgII Master Curve Control (aTgII MCM) (11207151)
ๅฎๆณฐๅฉๅก่ๅ
ๆณจๅฐๆ็ฒ็ถ่
บ็่็ฝII(aTgII)(11201759,11201761),ๅฎๆณฐๅฉๅกaTgII่ดจ้ๆงๅถ(aTgII QC)(11201752),ๅฎๆณฐๅฉๅกaTgIIไธปๆฒ็บฟๆงๅถ(aTgII MCM)(11207151)