Pure Global

Abbott Point of Care i-STAT® ß-hCG Cartridge - HSA Registration DE0018419

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 Database
Powered by Pure Global AI
HSA Official Data
CLASS B IVD
DE0018419
Abbott Point of Care i-STAT® ß-hCG Cartridge
HSA Registration Number: DE0018419
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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

Device 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 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