Singapore HSA registration DE0007256
Abbott Point of Care I-STAT® Cartridges (Chem8+, 6+, EC4+, E3+, G)
Singapore·CLASS C IVD·Abbott Point of Care Inc.·Registered July 11, 2011Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Clinical chemistry
- HSA Product Code
- HSAMDC00106
- HS Code
- 38220090
Registration information
- Registration Number
- DE0007256
- Registration Date
- July 11, 2011
- Change Notification Approval Date
- January 16, 2025
- Retention Due Date
- July 10, 2025
Product description
I-STAT Cartridges Chem8+, 6+, EC4+, E3+, and G are intended to be use with I-Stat® Portable Clinical Analyzer (Model 200) and I-Stat® 1 Analyzer (Model 300) for in vitro quantification of the following analytes in whole blood, respectively: Chem8+: sodium; potassium; chloride; TCO2; anion gap; ionized calcium; glucose; urea nitrogen; creatine; hemtatocrit; hemoglobin; 6+: sodium; potassium; chloride; glucose; urea nitrogen; hemtatocrit; hemoglobin; EC4+: sodium; potassium; chloride; glucose; hemtatocrit; hemoglobin; E3+: sodium; potassium; hemtatocrit; hemoglobin; and G: glucose. All cartridges should be used by healthcare professional trained to use the system.
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 6+ Cartridges i-Stat EC4+ Cartridges i-Stat E3+ Cartridges i-Stat G Cartridges 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 TriControls Calibration Verification Set Levels 1-5 i-Stat TriControls Control Level 1 i-Stat TriControls Control Level 2 i-Stat TriControls Control Level 3 Electronic Stimulator i-Stat Control Level 1 i-Stat CHEM8+ Calibration Verification Level 1b i-Stat Control Level 2 i-Stat Control Level 3 i-Stat 1 Analyzer Model 300 I-Stat 1 power cord IR Link for Portable Clinical Analyzer Martel Printer for i-Stat Portable Clinical Analyzer i-Stat, 9V Lithium Batteries (6each/box) Portable Printer Software download kit 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) Central Data Station Version 5, Software for Cartrige management / QC Manager software for PCx glucose tests strip management / Data Manager Printer / Central Data Station Version 5, Software for Cartrige management i-STAT Chem 8+ cartridge Portable Printer Analyzer programming kit i-Stat printer roll
- Model Identifier(s)
- 02R60-01 02R61-01 02R62-01 02R63-01 02R64-05 03P80-25 03P81-25 03P82-25 03P83-25 04J51-01 04P73-04 04P74-01 04P74-02 04P74-03 04P74-04 04P75-01 05P70-01 05P71-01 05P72-01 05P73-01 06F11-01 06F12-01 06F12-14 06F13-01 06F14-01 06F16-10 06F16-39 06F17-20 06F17-21 06F21-26 06F21-35 06F22-16 06F23-43 06F23-44 06F23-45 06F23-46 06F23-55 06F23-60 09P31-25 112100 112210 TMBT0003
About this record
Access comprehensive regulatory information for Abbott Point of Care I-STAT® Cartridges (Chem8+, 6+, EC4+, E3+, G) 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 DE0007256 and owned by Abbott Point of Care Inc.. The device was registered on July 11, 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