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Siemens DCAโ„ข Systems Microalbumin/Creatinine - HSA Registration DE0012499

Access comprehensive regulatory information for Siemens DCAโ„ข Systems 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 DE0012499 and owned by Simens Healthcare Diagnostics Inc.. The device was registered on March 04, 2013.

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.

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CLASS B IVD
DE0012499
Siemens DCAโ„ข Systems Microalbumin/Creatinine
HSA Registration Number: DE0012499
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Product Description

The DCA Microalbumin/Creatinine assay is a convenient, quantitative method for measuring low concentrations of albumin, creatinine, and the albumin/creatinine ratio in urine. The method is designed for decentralized testing using random, overnight, or timed specimens with results available to the patient within seven minutes. Testing for microalbuminuria (low concentrations of albumin in the urine) is recommended in patients with insulin-dependent diabetes mellitus (IDDM) as well as patients with non-insulin-dependent diabetes mellitus (NIDDM).This assay is intended for use in both screening for, and monitoring treatment of, microalbuminuria.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
HSA Product Code
HSAMDB00106
HS Code
38220090
Registration Information
Registration Number
DE0012499
Registration Date
March 04, 2013
Change Notification Approval Date
July 31, 2024
Retention Due Date
March 03, 2026
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)
DCAโ„ข Vantage Analyzer DCA Systems Microalbumin/ Creatinine Reagent Kit DCA Systems Microalbumin/ Creatinine Control Kit DCA Systems Microalbumin/ Creatinine Capillary Holders and Plungers DCA Systems Hemoglobin A1c Capillary holders RAPIDComm V6.0 Core License RAPIDComm v6.0 Blood Gas Modality License RAPIDComm v6.0 Cardiac Modality License RAPIDComm v6.0 Diabetes Modality License RAPIDComm v6.0 Urinalysis Modality License RAPIDComm v6.0 IT Care Plan
Model Identifier(s)
10282970 10311480 10325406 10888739 10888741 11065134 11065139 11065140 11065141 11065142 11065447