240124
B
current
IVD Test Reagent/Kits, Immunoassay, Vitamin, B12 (Cyanocobalamin)ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็,ๅ ็ซๆตๅฎ,็ปด็็ด ,B12(ๆฐฐ้ด่บ็ด )
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Vitamin, B12 (Cyanocobalamin). 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, B12 (Cyanocobalamin)
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็,ๅ ็ซๆตๅฎ,็ปด็็ด ,B12(ๆฐฐ้ด่บ็ด )
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
19141
Product Code Detail
19141 IVD Test Reagent/Kits, Immunoassay, Vitamin, B12 (Cyanocobalamin)
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
April 18, 2024
Expiry Date
April 17, 2029
Product Models
Atellica IM Vitamin B12 (VB12) (10995714, 10995715), Atellica IM Vitamin B12 DTT/Releasing Agent (VB12 DTT/REL) (10995718), Atellica IM Vitamin B12 Diluent (VB12 DIL) (10995716)
Atellica IM ็ปด็็ด B12 (VB12) (10995714, 10995715), Atellica IM ็ปด็็ด B12 DTT/่ฑๆจกๅ (VB12 DTT/REL) (10995718), Atellica IM ็ปด็็ด B12 ็จ้ๅ (VB12 DIL) (10995716)