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Siemens Atellica VTLi hs-cTnI Reagent Cartridge - HSA Registration DE0509543

Access comprehensive regulatory information for Siemens Atellica VTLi hs-cTnI Reagent Cartridge in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0509543 and owned by Siemens Healthcare Diagnostics Inc. The device was registered on July 17, 2024.

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 C IVD
DE0509543
Siemens Atellica VTLi hs-cTnI Reagent Cartridge
HSA Registration Number: DE0509543
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Product Description

Atellicaยฎ VTLi hsโ€‘cTnI Reagent Cartridges are for in vitro diagnostic use in the quantitative measurement of cardiac troponinI (cTnI) in human capillary (fingerstick) whole blood, and lithium-heparinized venous whole blood or plasma, using the Atellicaยฎ VTLi Immunoassay Analyzer. The reagent cartridges are to be used by healthcare professionals at the point of care (POC) as well as in the clinical laboratory. The reagent cartridges are to be used as an aid in the diagnosis of myocardial infarction (MI).

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0509543
Registration Date
July 17, 2024
Retention Due Date
July 16, 2025
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)
Atellica VTLi Analyzer Starter Kit Atellica VTLi Immunoassay Analyzer Atellica VTLi Docking Station Atellica VTLi hs-cTnI Reagent Cartridge Pathonorm Cardiac Acute Liq L-1 Pathonorm Cardiac Acute Liq L-2 Pathonorm Cardiac Acute Liq L-3
Model Identifier(s)
11555586 11555589 11555591 11555609 11555717 11555718 11555719