Singapore HSA registration DE0510612
Abbott Point of Care i-STAT PTplus
Singapore·CLASS C IVD·Abbott Point of Care Inc.·Registered April 21, 2025Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Hematology
Registration information
- Registration Number
- DE0510612
- Registration Date
- April 21, 2025
- Retention Due Date
- April 20, 2026
Product description
The i-STAT PTplus cartridge is intended for use in the in vitro quantitative measurement of the clot time of the extrinsic coagulation pathway when activated by thromboplastin in non-anticoagulated whole blood (venous or capillary), using the i-STAT 1 System. Measurements of prothrombin time are used to aid in the monitoring of patients receiving anticoagulant therapy with coumarin derivatives. The i-STAT PTplus Prothrombin Time test result is reported in seconds and as an International Normalized Ratio (INR). The test is intended for point of care use and is for prescription use only.
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 Wireless Analyzer i-STAT PTplus Cartridge Ceramic Conditioning cartridge i-STAT® 1 Downloader/Recharger i-STAT® 1 Downloader/Recharger Cable Kit i-STAT 1 Downloader/Recharger i-STAT Printer i-STAT Printer Power Supply I-STAT Printer Rechargeable Battery i-STAT Printer Kit i-STAT 1 Analyzer i-STAT Electronic Simulator Power Cord Ultralife 9V Lithium Batteries i-STAT 1 9V NiMH Battery i-STAT Dispensing Tip i-STAT PTplus Control Level 1 i-STAT PTplus Control Level 2
- Model Identifier(s)
- 03P75-06 03P89-50 04J51-01 04P73-01 04P73-03 04P73-04 04P74-01 04P74-02 04P74-03 04P74-04 04P75-01 06F11-01 06F16-43 06F21-26 06F23-55 06F24-20 06P17-17 06P17-18
About this record
Access comprehensive regulatory information for Abbott Point of Care i-STAT PTplus 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 DE0510612 and owned by Abbott Point of Care Inc.. The device was registered on April 21, 2025.
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