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Abbott Point of Care i-STAT® PT/INR Cartridge - HSA Registration DE0501486

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.

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CLASS C IVD
DE0501486
Abbott Point of Care i-STAT® PT/INR Cartridge
HSA Registration Number: DE0501486
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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.

Device 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 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