Singapore HSA registration DE0018419
Abbott Point of Care i-STAT® ß-hCG Cartridge
Singapore·CLASS B IVD·Abbott Point of Care Inc.·Registered July 29, 2016Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0018419
- Registration Date
- July 29, 2016
- Change Notification Approval Date
- January 06, 2025
- Retention Due Date
- July 28, 2025
Product description
The i-STAT® Total Beta-Human Chorionic Gonadotropin (β-hCG) assay is an in vitro diagnostic test for the quantitative and qualitative determination of beta-human chorionic gonadotropin in whole blood or plasma samples. β-hCG can be used for the detection of early pregnancy
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)
- CDS Database Setup i-STAT® Total ß-hCG Control Level 1 i-STAT® Total ß-hCG Control Level 2 i-STAT® Total ß-hCG Control Level 3 i-STAT®1 Wireless Analyzer, MN: 300W Central Data Station Software Upgrade 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® Total ß-hCG Cartridge i-STAT® Total ß-hCG Control Calibration Verification Kit 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
- Model Identifier(s)
- 013859-01 02R29-01 02R29-02 02R29-03 03P75-06 040312-01 01 04J51-01 04P73-01 04P73-03 04P73-04 04P74-01 04P74-02 04P74-03 04P74-04 04P75-01 05P58-25 05P59-04 06F11-01 06F16-10 06F16-43 06F21-26 06F23-43 06F23-44 06F23-45 06F23-46 06F23-55
About this record
Access comprehensive regulatory information for Abbott Point of Care i-STAT® ß-hCG Cartridge in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0018419 and owned by Abbott Point of Care Inc.. The device was registered on July 29, 2016.
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 B IVD