Alere Cholestech LDX®

Basic Information

• Brand Name: Alere Cholestech LDX®
• Primary DI: 00854361008003
• Version / Model: 14875
• Catalog Number: 14875
• Company Name: ALERE SAN DIEGO, INC.
• Labeler DUNS: 194854949
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-30
• Public Version: 3
• Public Version Date: 2023-12-21
• Public Version Status: Update
• Public Device Record Key: 8960ae8a-0d2c-41f8-b232-0c1d4a3f423f
• Distribution End Date: 2022-05-26

Device Description

Alere Cholestech LDX® Analyzer

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJF	Analyzer, Chemistry, Micro, For Clinical Use	Clinical Chemistry	862.2170	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42625	Photometric/spectroscopic immunoassay analyser IVD	An electrically-powered instrument intended to be used to scan an immunoassay reagent vehicle (e.g., test strip, cassette, or card), after vehicle exposure to a clinical specimen, to provide a quantitative, semi-quantitative and/or qualitative in vitro determination of chemical substances and/or biological markers in the clinical specimen. The instrument uses photometry and/or light spectroscopy to detect visual markers that result from the immunological reaction between the reagents and the specimen. It is intended to be used by healthcare professionals for rapid in vitro diagnostic measurements [e.g., lateral flow immunochromatographic (ICT) test] at the point-of-care or in the laboratory.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00854361008003	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 2 – 30 Degrees Celsius