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Siemens Atellica DCAโ„ข HbA1c Dx - HSA Registration DE0507575

Access comprehensive regulatory information for Siemens Atellica DCAโ„ข HbA1c Dx 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 DE0507575 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.

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CLASS B IVD
DE0507575
Siemens Atellica DCAโ„ข HbA1c Dx
HSA Registration Number: DE0507575
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Product Description

Atellica DCA HbA1c assay is an in vitro diagnostic test for quantitative determination of mmol/mol of Hemoglobin A1c (HbA1c) (IFCC) and % HbA1c (DCCT/NGSP) in human venous and capillary whole blood. This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. The measurement of HbA1c is recommended as a marker of long-term metabolic control in persons with diabetes mellitus.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0507575
Registration Date
December 06, 2022
Change Notification Approval Date
October 02, 2023
Retention Due Date
December 05, 2025
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)
Atellica DCA Analyzer HbA1c Dx Reagent Kit Atellica DCA Analyzer HbA1c Controls Atellica POC Solution Adaptor Ethernet Kit Atellica DCA Analyzer Atellica POC Solution Display Atellica DCA Analyzer HbA1c Capillary Holder Optical Test Cartridge Air filter (2 pack) Cleaning Kit Atellica POC Solution Adaptor Atellica DCA Module
Model Identifier(s)
10888771 11317549 11317926 11419264 11419268 11419358 11420519 11420524 11420525 11538022 11561560