Singapore HSA registration DE0007255
Abbott Point of Care i-STAT® cTnI Cartridge
Singapore·CLASS C IVD·Abbott Point of Care Inc.·Registered July 11, 2011Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
- HSA Product Code
- HSAMDC00106
- HS Code
- 38220090
Registration information
- Registration Number
- DE0007255
- Registration Date
- July 11, 2011
- Change Notification Approval Date
- December 30, 2024
- Retention Due Date
- July 10, 2025
Product description
The i-STAT® cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
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® Wireless Analyzer MN: 300W i-STAT® cTnI Cartridge 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 power cord User Guide IR Link for Portable Clinical Analyzer Martel Printer for i-Stat Portable Clinical Analyzer IR Link for Portable Clinical Analyzer i-Stat, 9V Lithium Batteries (6each/box) Portable Printer battery for martel printer 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/batt pack) Central Data Station Version 5 Martel Printer for i-Stat Portable Clinical Analyzer i-STAT cTnI Control Level 1 i-STAT cTnI Control Level 2 i-STAT cTnI Control Level 3 i-STAT cTnI Calibration Verification Control Set Levels 1-3 i-STAT® cTnI Cartridge i-Stat printer roll
- Model Identifier(s)
- 03P75-06 03P90-25 04J51-01 04P73-04 04P74-01 04P74-02 04P74-03 04P74-04 04P75-01 06F11-01 06F16-10 06F16-39 06F16-57 06F17-20 06F17-21 06F21-20 06F21-26 06F21-35 06F23-45 06F23-46 06F23-55 06F23-60 06F23-91 06P17-09 06P17-10 06P17-11 06P17-12 06P23-25 TMBT0003
About this record
Access comprehensive regulatory information for Abbott Point of Care i-STAT® cTnI 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 DE0007255 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