240041
B
current
IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Hormone, Parathyroid Hormone, Intactไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็,ๅ ็ซๆตๅฎ,้ชจไปฃ่ฐขๆฟ็ด ,็ฒ็ถๆ่ บๆฟ็ด ,ๅฎๆด
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Hormone, Parathyroid Hormone, Intact. 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, Bone Metabolism Hormone, Parathyroid Hormone, Intact
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็,ๅ ็ซๆตๅฎ,้ชจไปฃ่ฐขๆฟ็ด ,็ฒ็ถๆ่ บๆฟ็ด ,ๅฎๆด
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
19883
Product Code Detail
19883 IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Hormone, Parathyroid Hormone, Intact
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 Intact Parathyroid Hormone (PTH) (10995621, 10995622), Atellica IM Intact Parathyroid Hormone Master Curve Material (PTH MCM) (10995625), Atellica IM Intact Parathyroid Hormone Quality Control (PTH QC) (10995626)
Atellica IM ๅฎๆด็ฒ็ถๆ่
บๆฟ็ด (PTH) (10995621, 10995622)ใAtellica IM ๅฎๆด็ฒ็ถๆ่
บๆฟ็ด ไธปๆฒ็บฟๆๆ (PTH MCM) (10995625)ใAtellica IM ๅฎๆด็ฒ็ถๆ่
บๆฟ็ด ่ดจ้ๆงๅถ (PTH QC) (10995626)