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Abbott Point of Care i-STAT CREA Cartridge - HSA Registration DE0007263

Access comprehensive regulatory information for Abbott Point of Care i-STAT CREA 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 DE0007263 and owned by Abbott Point of Care Inc.. The device was registered on July 12, 2011.

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
DE0007263
Abbott Point of Care i-STAT CREA Cartridge
HSA Registration Number: DE0007263
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Product Description

The i-STAT Crea cartridge with the i-STAT 1 System and i-STAT Alinity System is intended for use in the in vitro quantification of creatinine in arterial, venous, or capillary whole blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0007263
Registration Date
July 12, 2011
Change Notification Approval Date
February 07, 2025
Retention Due Date
July 11, 2025
Product Owner
Short Name
Abbott Point of Care Inc.
Address
400 College Road East, Princeton, NJ 08540, UNITED STATES
Registrant
Address
5 JALAN KILANG BARAT, PETRO CENTRE, #09-05, SINGAPORE 159349
Importer
Address
1 KALLANG PLACE, SINGAPORE 339211 5 JALAN KILANG BARAT, PETRO CENTRE, #09-00, SINGAPORE 159349
Model Information
Model Name(s)
i-STAT Alinity Instrument (Model No. AN-500) i-STAT Alinity Base Station (Model No. BST-500) i-STAT Alinity Electronic Simulator (Model No. ES-500) i-STAT Alinity Battery (Model No. RB-500) i-STAT Alinity Printer Kit i-Stat Crea Cartridge Ceramic Conditioning Cartridge i-Stat Downloader Recharger Kit i-Stat 1 Printer i-Stat Power Supply i-Stat Printer Rechargeable Battery i-Stat 1 Printer Kit i-Stat 1 Analyzer Model 300G Electronic Stimulator i-Stat Control Level 1 i-Stat Control Level 2 i-Stat Control Level 3 i-Stat Calibration Verification Set, Levels 1-5 i-Stat 1 Analyzer Model 300 i-Stat 1 Analyzer, System Manual, English i-Stat 1 power cord User Guide IR link with printer cradle i-Stat, 9V Lithium Batteries (6each/box) Portable Printer Software download kit i-Stat Portable Clinical Analyzer, System Manual, English Downloader and/or Downloader/Recharger for i-Stat 1 Analyser Downloader and/or Downloader/Recharger for i-Stat 1 Analyser Downloader and/or Downloader/Recharger for i-Stat 1 Analyser Downloader and/or Downloader/Recharger for i-Stat 1 Analyser i-Stat 1 9V Niam Battery (recharger/battery pack) Portable Printer Analyzer programming kit i-Stat printer roll
Model Identifier(s)
02R60-01 02R61-01 02R62-01 02R63-01 02R64-05 03P84-25 04J51-01 04P73-04 04P74-01 04P74-02 04P74-03 04P74-04 04P75-01 06F11-01 06F12-01 06F13-01 06F14-01 06F15-01 06F16-10 06F16-32 06F16-39 06F16-57 06F21-20 06F21-26 06F21-35 06F22-16 06F23-26 06F23-43 06F23-44 06F23-45 06F23-46 06F23-55 06F23-91 112210 TMBT0003