Singapore HSA registration DE0007253
Abbott Point of Care i-STAT Kaolin Activated Clotting Time Cartridge
Singapore·CLASS C IVD·Abbott Point of Care Inc.·Registered July 11, 2011Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Hematology
- HSA Product Code
- HSAMDC00106
- HS Code
- 38220090
Registration information
- Registration Number
- DE0007253
- Registration Date
- July 11, 2011
- Change Notification Approval Date
- December 30, 2024
- Retention Due Date
- July 10, 2025
Product description
It is an in vitro diagnostic test that uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery. The test is to be used with the i-STAT Portable Clinical Analyzer and the i-STAT 1 Analyzer, but not the Philips Medical Systems (formerly Agilent Technologies) Blood Analysis Module (BAM).
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 ACTk 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 Electronic Stimulator 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 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 Martel Printer for i-Stat Portable Clinical Analyzer i-STAT ACT Control Level 1 i-STAT ACT Control Level 2 Analyzer programming kit i-Stat printer roll
- Model Identifier(s)
- 03P87-25 04J51-01 04P73-04 04P74-01 04P74-02 04P74-03 04P74-04 04P75-01 06F11-01 06F16-10 06F16-32 06F16-39 06F16-57 06F21-20 06F21-26 06F21-35 06F22-16 06F23-43 06F23-44 06F23-45 06F23-46 06F23-55 06F23-60 06F23-91 06P17-15 06P17-16 112210 TMBT0003
About this record
Access comprehensive regulatory information for Abbott Point of Care i-STAT Kaolin Activated Clotting Time 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 DE0007253 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