240040
B
current
IVD Test Reagent/Kits, Immunoassay, Vitamin, D Metabolite, 25-Hydroxyvitamin Dไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ็ปด็็ด ใD ไปฃ่ฐข็ฉใ25-็พๅบ็ปด็็ด D
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Vitamin, D Metabolite, 25-Hydroxyvitamin D. 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, Vitamin, D Metabolite, 25-Hydroxyvitamin D
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ็ปด็็ด ใD ไปฃ่ฐข็ฉใ25-็พๅบ็ปด็็ด D
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
19142
Product Code Detail
19142 IVD Test Reagent/Kits, Immunoassay, Vitamin, D Metabolite, 25-Hydroxyvitamin D
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 Vitamin D Total (VitD) (10995719, 10995720), Atellica IM Vitamin D Total Quality Control (VitD QC) (10995724), Atellica IM Vitamin D Total Diluent (VitD DIL) (10995721)
Atellica IM ็ปด็็ด D ๆป้ (VitD) (10995719, 10995720), Atellica IM ็ปด็็ด D ๆป่ดจ้ๆงๅถ (VitD QC) (10995724), Atellica IM ็ปด็็ด D ๆป็จ้ๅ (VitD DIL) (10995721)