Singapore HSA registration DE0016621
Siemens DCA™ System Hemoglobin A1c Reagent Kit
Singapore·CLASS B IVD·Siemens Healthcare Diagnostics Inc·Registered December 05, 2014Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
- HSA Product Code
- HSAMDB00106
- HS Code
- 38220090
Registration information
- Registration Number
- DE0016621
- Registration Date
- December 05, 2014
- Change Notification Approval Date
- July 31, 2024
- Retention Due Date
- December 04, 2025
Product description
The Siemens Healthcare Diagnostics DCA HbA1c test can be an aid to diagnose diabetes and identify patients at risk for developing diabetes, monitoring the long-term care of patients with diabetes. This assay provides a convenient, quantitative method for measuring the percent concentration of hemoglobin A1c in blood. The DCA HbA1c assay is for use in laboratories such as physician office laboratories, clinics, and hospitals.
Product Owner
- Short Name
- Siemens Healthcare, USA
- Address
- 511 Benedict Avenue, Tarrytown, NY 10591, UNITED STATES
Registrant
- Address
- 60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Importer
- Address
- 219 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #08-02, SINGAPORE 159556 60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model information
- Model Name(s)
- DCA Vantage Analyzer DCA Normal & Abnormal Control Kit HbA1c Capillary Holder (strip of 11) DCA Systems HbA1c Reagent Kit DCA Systems Microalbumin/ Creatinine Capillary Holders and Plungers DCA Systems Hemoglobin A1c Capillary holders
- Model Identifier(s)
- 10282970 10311161 10314620 10698915 10888739 10888741
About this record
Access comprehensive regulatory information for Siemens DCA™ System Hemoglobin A1c Reagent Kit in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0016621 and owned by Siemens Healthcare Diagnostics Inc. The device was registered on December 05, 2014.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD