Singapore HSA registration DE0501486
Abbott Point of Care i-STAT® PT/INR Cartridge
Singapore·CLASS C IVD·Abbott Point of Care Inc.·Registered April 09, 2018Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Hematology
Registration information
- Registration Number
- DE0501486
- Registration Date
- April 09, 2018
- Change Notification Approval Date
- December 30, 2024
- Retention Due Date
- April 08, 2026
Product description
The i-STAT® PT/INR test is a whole blood determination of the prothrombin time used for monitoring oral anticoagulant (Coumadin or warfarin) therapy.
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
- 5 JALAN KILANG BARAT, PETRO CENTRE, #09-00, SINGAPORE 159349
Model information
- Model Name(s)
- i-STAT®1 Wireless Analyzer, MN: 300W i-STAT® PT/INR Cartridge i-STAT® Ceramic Conditioning Cartridge i-STAT® 1 Downloader/Recharger i-STAT® 1 Downloader/Recharger Cable Kit i-STAT® 1 Downloader/Recharger Kit i-STAT®1 Printer i-STAT® Combo Power Supply i-STAT® Printer Rechargeable Battery i-STAT® Printer Kit i-STAT®1 Analyzer, MN: 300-G i-STAT® Electronic Simulator i-STAT®1 Analyzer, MN:300 Downloader/Recharger Power Cord i-STAT®1 9V Lithium Batteries SERIAL DOWNLOADER (RGA Only) NETWORK DOWNLOADER (RGA Only) DOWNLOADER RECHARGER SERIAL DESKTOP (RGA Only) DOWNLOADER RECHARGER NETWORK DESKTOP(RGA Only) i-STAT®1 9V NiMH Battery i-STAT® PT Control Level 1 i-STAT® PT Control Level 2
- Model Identifier(s)
- 03P75-06 03P89-24 04J51-01 04P73-01 04P73-03 04P73-04 04P74-01 04P74-02 04P74-03 04P74-04 04P75-01 06F11-01 06F16-10 06F16-43 06F21-26 06F23-43 06F23-44 06F23-45 06F23-46 06F23-55 06P17-13 06P17-14
About this record
Access comprehensive regulatory information for Abbott Point of Care i-STAT® PT/INR 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 DE0501486 and owned by Abbott Point of Care Inc.. The device was registered on April 09, 2018.
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