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Abbott Point of Care I-Stat® Cartridges (EC8+, CG8+, EG7+, EG6+, CG4+ G3+) - HSA Registration DE0007257

Access comprehensive regulatory information for Abbott Point of Care I-Stat® Cartridges (EC8+, CG8+, EG7+, EG6+, CG4+ G3+) 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 DE0007257 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.

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HSA Official Data
CLASS C IVD
DE0007257
Abbott Point of Care I-Stat® Cartridges (EC8+, CG8+, EG7+, EG6+, CG4+ G3+)
HSA Registration Number: DE0007257
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Product Description

i-Stat Cartridges EC8+, CG8+, EG7+, EG6+, CG4+ and G3+ are intended to be use with I-Stat® Portable Clinical Analyzer (Model 200) and I-Stat® 1 Analyzer (Model 300) for in vitro quantification of the following analytes in whole blood, respectively: EC8+: sodium; potassium; chloride; anion gap; glucose; urea nitrogen; hemtatocrit; hemoglobin; pH; PCO2; TCO2; HCO3; and base excess; CG8+: sodium; potassium; ionized calcium; glucose; hemtatocrit; hemoglobin; pH; PCO2; PO2; TCO2; HCO3; base excess; and sO2; EG7+: sodium; potassium; ionized calcium; hemtatocrit; hemoglobin; pH; PCO2; PO2; TCO2; HCO3; base excess; and sO2; EG6+: sodium; potassium; hemtatocrit; hemoglobin; pH; PCO2; PO2; TCO2; HCO3; base excess; and sO2; CG4+: lactate; hemtatocrit; hemoglobin; pH; PCO2; PO2; TCO2; HCO3; base excess; and sO2; G3+: pH; PCO2; PO2; TCO2; HCO3; base excess; and sO2. All cartridges should be used by healthcare professional trained to use the system.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Clinical chemistry
HSA Product Code
HSAMDC00106
HS Code
38220090
Registration Information
Registration Number
DE0007257
Registration Date
July 11, 2011
Change Notification Approval Date
February 07, 2025
Retention Due Date
July 10, 2025
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 Alinity Instrument (Model No. AN-500) i-STAT Alinity Base Station (Model No. BST-500) i-STAT Alinity Electronic Simulator (Model No. ES-500) i-STAT Alinity Battery (Model No. RB-500) i-STAT Alinity Printer Kit i-STAT® Wireless Analyzer MN: 300W i-Stat EG7+ Cartridges i-Stat EG6+ Cartridges i-Stat G3+ Cartridges i-Stat G3+ Cartridge i-Stat EC8+Cartridges i-STAT CG4+ Cartridge i-STAT® CG4+ Cartridge i-Stat CG8+Cartridges Ceramic Cartridge i-STAT®1 DOWNLOADER/RECHARGER CABLE KIT i-STAT® 1 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 i-STAT® Electronic Simulator i-Stat Control Level 1 i-Stat Control Level 2 i-Stat Control Level 3 i-Stat Calibration Verification Set, Levels 1-5 i-Stat 1 Analyzer Model 300 i-Stat 1 power cord Power Cord User Guide i-Stat, 9V Lithium Batteries (6each/box) 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 i-Stat printer roll
Model Identifier(s)
02R60-01 02R61-01 02R62-01 02R63-01 02R64-05 03P75-06 03P76-25 03P77-25 03P78-25 03P78-50 03P79-25 03P85-25 03P85-50 03P88-25 04J51-01 04P73-03 04P73-04 04P74-01 04P74-02 04P74-03 04P74-04 04P75-01 06F11-01 06F12-01 06F13-01 06F14-01 06F15-01 06F16-10 06F16-39 06F16-43 06F16-57 06F21-26 06F23-43 06F23-44 06F23-45 06F23-46 06F23-55 06F23-60 TMBT0003 (06F17-11)