240369
IVD Test Reagent/Kits, Immunoassay, Renal Metabolism, Cortisol
体外诊断 测试试剂/试剂盒、免疫测定、肾脏代谢、皮质醇
Siemens Healthcare Diagnostics Inc.·B·Hong Kong MDACS·Registered September 11, 2024
Device overview
- Risk class
- B
- Product code
- 19131
- State
- current
- Status
- N/A
- Product code detail
- 19131 IVD Test Reagent/Kits, Immunoassay, Renal Metabolism, Cortisol
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 Cortisol (Cor) (10995537, 10995538), Atellica IM Calibrator E (CAL E) (10995512, 10995513), Atellica IM Cortisol Urine Reconstitution Buffer (10995540)
Atellica IM 皮质醇 (COR) (10995537, 10995538), Atellica IM 校准器 E (CAL E) (10995512, 10995513), Atellica IM 皮质醇尿液重建缓冲液 (10995540)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Renal Metabolism, Cortisol. 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, Renal Metabolism, Cortisol
產品資訊： 体外诊断 测试试剂/试剂盒、免疫测定、肾脏代谢、皮质醇