240034
B
current
IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Triiodothyronineไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ็ฒ็ถ่ บๆฟ็ด ใไธ็ข็ฒ็ถ่ บๅๆฐจ้ ธ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Triiodothyronine. 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, Thyroid Hormone, Triiodothyronine
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ็ฒ็ถ่ บๆฟ็ด ใไธ็ข็ฒ็ถ่ บๅๆฐจ้ ธ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
19109
Product Code Detail
19109 IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Triiodothyronine
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Siemens Healthcare Diagnostics Inc.
Siemens Healthcare Diagnostics Inc
United States
็พๅฝ
511 Benedict Ave, Tarrytown NY 10591, USA
511ๆฌๅฐผ่ฟชๅ
็นๅคง้,็บฝ็บฆๅก้ๆฆ10591,็พๅฝ
Authorised Representative (AR)
Siemens Healthcare Limited
่ฅฟ้จๅญๅป็ๆ้ๅ
ฌๅธ
25833388
Regulatory Timeline
Registration Date
February 06, 2024
Expiry Date
February 06, 2029
Product Models
Atellica IM Total Triiodothyronine (T3) (10995678, 10995679), Atellica IM T3/T4/VB12 Ancillary Reagent (T3/T4/VB12ANC) (10995682, 10995683), Atellica IM Total Triiodothyronine Diluent (T3 DIL) (10995680)
Atellica IM ๆปไธ็ข็ฒ็ถ่
บๅๆฐจ้
ธ (T3) (10995678, 10995679), Atellica IM T3/T4/VB12 ่พ
ๅฉ่ฏๅ (T3/T4/VB12ANC) (10995682, 10995683), Atellica IM ๆปไธ็ข็ฒ็ถ่
บๅๆฐจ้
ธ็จ้ๅ (T3 DIL) (10995680)