Singapore HSA registration DE0507574
Siemens Atellica DCA™ Microalbumin/Creatinine
Singapore·CLASS B IVD·Simens Healthcare Diagnostics Inc.·Registered December 06, 2022Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0507574
- Registration Date
- December 06, 2022
- Change Notification Approval Date
- November 04, 2024
- Retention Due Date
- December 05, 2025
Product description
Atellica DCA ACR assay is an in vitro diagnostic test for quantitative determination of albumin, creatinine, and albumin/creatinine ratio (ACR) in human urine. The measurement of urine albumin, creatinine and albumin/ creatinine ratio, aids in the early diagnosis of kidney disease, screening and monitoring of microalbuminuria.
Product Owner
- Short Name
- Siemens Health
- Address
- 511 Benedict Avenue, Tarrytown, New York 10591-5097, New York, 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 Systems Microalbumin/Creatinine Control Kit Atellica DCA ACR Reagent Kit Atellica POC Solution Adaptor Ethernet Kit Atellica DCA Analyzer Atellica POC Solution Display Atellica DCA Analyzer ACR Capillary Holders and Plungers Optical Test Cartridge Air filter (2 pack) Cleaning Kit Atellica POC Solution Adaptor Atellica DCA Module
- Model Identifier(s)
- 10325406 (6012A) 10888779 11317926 11419264 11419268 11419359 11420519 11420524 11420525 11538022 11561560
About this record
Access comprehensive regulatory information for Siemens Atellica DCA™ Microalbumin/Creatinine 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 DE0507574 and owned by Simens Healthcare Diagnostics Inc.. The device was registered on December 06, 2022.
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