Alere Cholestech LDX® 14-531

GUDID 04571226470831

Alere Cholestech LDX® Lipid Profile●GLU

ALERE SAN DIEGO, INC.

Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry

• Primary Device ID: 04571226470831
• NIH Device Record Key: 2ae037a3-48c7-4218-bba6-8d6173e87156
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alere Cholestech LDX®
• Version Model Number: 14-531
• Catalog Number: 14-531
• Company DUNS: 194854949
• Company Name: ALERE SAN DIEGO, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +18773088289
• Email: USproductsupport@alere.com
• Phone: +18773088289
• Email: USproductsupport@alere.com
• Phone: +18773088289
• Email: USproductsupport@alere.com
• Phone: +18773088289
• Email: USproductsupport@alere.com
• Phone: +18773088289
• Email: USproductsupport@alere.com
• Phone: +18773088289
• Email: USproductsupport@alere.com
• Phone: +18773088289
• Email: USproductsupport@alere.com
• Phone: +18773088289
• Email: USproductsupport@alere.com
• Phone: +18773088289
• Email: USproductsupport@alere.com
• Phone: +18773088289
• Email: USproductsupport@alere.com
• Phone: +18773088289
• Email: USproductsupport@alere.com
• Phone: +18773088289
• Email: USproductsupport@alere.com
• Phone: +18773088289
• Email: USproductsupport@alere.com
• Phone: +18773088289
• Email: USproductsupport@alere.com
• Phone: +18773088289
• Email: USproductsupport@alere.com
• Phone: +18773088289
• Email: USproductsupport@alere.com
• Phone: +18773088289
• Email: USproductsupport@alere.com
• Phone: +18773088289
• Email: USproductsupport@alere.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04571226470831 [Primary]

FDA Product Code

• CGA: Glucose Oxidase, Glucose

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-06-29

On-Brand Devices [Alere Cholestech LDX®]

• 00854361008003: Alere Cholestech LDX® Analyzer
• 04571226470831: Alere Cholestech LDX® Lipid Profile●GLU
• 00893038002845: Alere Cholestech LDX® Multianalyte Controls
• 00893038002210: Alere Cholestech LDX® Multianalyte Controls (2 X 2ml)
• 00899722002344: Alere Cholestech LDX® Lipid Profile GLU
• 00893038002654: Alere Cholestech LDX® Lipid Profile GLU
• 00893038002647: Alere Cholestech LDX® TC HDL GLU
• 00893038002630: Alere Cholestech LDX® Lipid Profile
• 00893038002623: Alere Cholestech LDX® TC GLU
• 00893038002616: Alere Cholestech LDX® TC HDL
• 00893038002609: Alere Cholestech LDX® TC
• 00893038002524: Alere Cholestech LDX® Optics Check Cassette