240367
IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA 27.29
体外诊断检测试剂/试剂盒、免疫检测、肿瘤标志物、碳水化合物抗原 CA 27.29
Siemens Healthcare Diagnostics Inc.·C·Hong Kong MDACS·Registered September 11, 2024
Device overview
- Risk class
- C
- Product code
- 19841
- State
- current
- Status
- N/A
- Product code detail
- 19841 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA 27.29
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, USA511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
- September 11, 2024
- Expiry date
- September 10, 2029
Product models
Atellica IM BR 27.29 (BR) (10995477, 10995478), Atellica IM BR 27.29 Calibrator (BR CAL) (10995515), Atellica IM BR 27.29 Pretreatment Reagent (BR PRE) (10995480)
Atellica IM BR 27.29 (BR) (10995477, 10995478), Atellica IM BR 27.29 校准剂 (BR CAL) (10995515), Atellica IM BR 27.29 预处理试剂 (BR PRE) (10995480)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA 27.29. 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, Tumor Marker, Carbohydrate Antigen CA 27.29
產品資訊: 体外诊断检测试剂/试剂盒、免疫检测、肿瘤标志物、碳水化合物抗原 CA 27.29