Pure Global
Singapore HSA registration DE0016545

Cholestech LDX™ Total Cholesterol System

Singapore flagSingapore·CLASS B IVD·Alere San Diego, Inc.·Registered November 18, 2014
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0016545
Registration Date
November 18, 2014
Change Notification Approval Date
November 16, 2023
Retention Due Date
November 17, 2025
Product description
For the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides and glucose in whole blood. A TC/HDL (total cholesterol/HDL cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are calculated by the Cholestech LDX™ Analyzer.
Product Owner
Name
Alere San Diego, Inc.
Short Name
Alere San Diego, Inc.
Address
9942 Mesa Rim Road, San Diego, CA 92121, UNITED STATES
Registrant
Name
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Name
ALL EIGHTS (SINGAPORE) PRIVATE LIMITED BIO LABORATORIES PTE LTD
Address
6 HARPER ROAD, LEONG HUAT BUILDING, #03-02, SINGAPORE 369674 10 UBI CRESCENT, UBI TECHPARK, #06-02, SINGAPORE 408564
Model information
Model Name(s)
Cholestech LDX™ Optics Check Cassette Cholestech LDX™ Capillary Plungers Cholestech LDX™ TC Total Cholesterol Cassette Cholestech LDX™ TC-HDL Cassette Cholestech LDX™ TC-GLU Cassette Cholestech LDX™ TC-HDL-GLU Cassette Cholestech LDX™ MiniPet® Pipette Tips Cholestech LDX™ Analyer Cholestech LDX™ MiniPet® Pipette , 40µL Cholestech LDX™ Analyzer Cholestech LDX™ Capillary Tubes 40µL Cholestech LDX™ Multianalyte Control L1 L2
Model Identifier(s)
10-228 10-311 10-986 10-987 10-988 10-990 11-010 12-282 13-014 14-875 52193 88769
About this record

Access comprehensive regulatory information for Cholestech LDX™ Total Cholesterol System 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 DE0016545 and owned by Alere San Diego, Inc.. The device was registered on November 18, 2014.

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