Singapore HSA registration DE0007263
Abbott Point of Care i-STAT CREA Cartridge
Singapore·CLASS C IVD·Abbott Point of Care Inc.·Registered July 12, 2011Device 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 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.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD