240039

IVD Test Reagent/Kits, Clinical Chemistry, Amino Acid, Homocysteine, Total

体外诊断 测试试剂/试剂盒, 临床化学, 氨基酸, 同型半胱氨酸, 总计
Siemens Healthcare Diagnostics Inc.·C·Hong Kong MDACS·Registered February 06, 2024
Device overview
Risk class
C
Product code
28034
State
current
Status
N/A
Product code detail
28034 IVD Test Reagent/Kits, Clinical Chemistry, Amino Acid, Homocysteine, Total
Manufacturer (製造商)
Name
Siemens Healthcare Diagnostics Inc.
Siemens Healthcare Diagnostics Inc
Country
United States
美国
Address
511 Benedict Ave, Tarrytown NY 10591, USA
511本尼迪克特大道,纽约塔里敦10591,美国
Authorised representative (AR)
Name
Siemens Healthcare Limited
西门子医疗有限公司
Phone
25833388
Regulatory timeline
Registration date
February 06, 2024
Expiry date
February 06, 2029
Product models
Atellica IM Homocysteine (HCY) (10995606, 10995607), Atellica IM Homocysteine Calibrator (HCY CAL) (10995498), Atellica IM Homocysteine Diluent (HCY DIL) (10995608)
Atellica IM 同型半胱氨酸 (HCY) (10995606, 10995607)、Atellica IM 同型半胱氨酸校准品 (HCY CAL) (10995498)、Atellica IM 同型半胱氨酸稀释剂 (HCY DIL) (10995608)
About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Clinical Chemistry, Amino Acid, Homocysteine, Total. 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, Clinical Chemistry, Amino Acid, Homocysteine, Total

產品資訊: 体外诊断 测试试剂/试剂盒, 临床化学, 氨基酸, 同型半胱氨酸, 总计