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Cholestech LDX™ Lipid Profile System - HSA Registration DE0016546

Access comprehensive regulatory information for Cholestech LDX™ Lipid Profile 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 DE0016546 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.

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CLASS B IVD
DE0016546
Cholestech LDX™ Lipid Profile System
HSA Registration Number: DE0016546
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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.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0016546
Registration Date
November 18, 2014
Change Notification Approval Date
November 24, 2023
Retention Due Date
November 17, 2025
Product Owner
Short Name
Alere San Diego, Inc.
Address
9942 Mesa Rim Road, San Diego, CA 92121, UNITED STATES
Registrant
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
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™ Lipid Profile Cassette Cholestech LDX™ Lipid Profile-GLU Cholestech LDX™ MiniPet® Pipette Tips Cholestech LDX™ Analyzer 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 10-989 10-991 11-010 12-282 13-014 14-875 52193 88769