Alere Cholestech LDX® 88769

GUDID 00893038002210

Alere Cholestech LDX® Multianalyte Controls (2 X 2ml)

ALERE SAN DIEGO, INC.

Multiple-type clinical chemistry analyte profile IVD, control

• Primary Device ID: 00893038002210
• NIH Device Record Key: 973dfba9-91b8-4a83-b555-f66a546c3ebe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alere Cholestech LDX®
• Version Model Number: 88769
• Catalog Number: 88769
• 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: false
• 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
• 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

• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00893038002210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102700

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

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: 2023-08-25
• Device Publish Date: 2018-03-30

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