Cholestech LDX™ 97989

GUDID 00893038002913

Cholestech LDX™ Lipid Profile

ALERE SAN DIEGO, INC.

Multiple lipid analyte IVD, reagent

• Primary Device ID: 00893038002913
• NIH Device Record Key: 97ce5862-b2c3-47f5-a551-5292e25bfc4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cholestech LDX™
• Version Model Number: 97989
• Catalog Number: 97989
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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: +18774417440
• Email: USproductsupport@abbott.com
• Phone: +18774417440
• Email: USproductsupport@abbott.com
• Phone: +18774417440
• Email: USproductsupport@abbott.com
• Phone: +18774417440
• Email: USproductsupport@abbott.com
• Phone: +18774417440
• Email: USproductsupport@abbott.com
• Phone: +18774417440
• Email: USproductsupport@abbott.com
• Phone: +18774417440
• Email: USproductsupport@abbott.com
• Phone: +18774417440
• Email: USproductsupport@abbott.com
• Phone: +18774417440
• Email: USproductsupport@abbott.com
• Phone: +18774417440
• Email: USproductsupport@abbott.com
• Phone: +18774417440
• Email: USproductsupport@abbott.com
• Phone: +18774417440
• Email: USproductsupport@abbott.com
• Phone: +18774417440
• Email: USproductsupport@abbott.com
• Phone: +18774417440
• Email: USproductsupport@abbott.com
• Phone: +18774417440
• Email: USproductsupport@abbott.com
• Phone: +18774417440
• Email: USproductsupport@abbott.com
• Phone: +18774417440
• Email: USproductsupport@abbott.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00893038002913 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223179

FDA Product Code

• JGY: Colorimetric Method, Triglycerides

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-28
• Device Publish Date: 2023-12-20

On-Brand Devices [Cholestech LDX™]

• 00893038002036: Cholestech LDX™ Multianalyte Controls (2 X 250µL)
• 00893038002029: Cholestech LDX™ Multianalyte Calibration Verification
• 00893038002012: Cholestech LDX™ Multianalyte Controls (2 X 2ml)
• 00893038002944: Cholestech LDX™ Optics Check Cassette
• 00893038002937: Cholestech LDX™ Lipid Profile GLU
• 00893038002920: Alere Cholestech LDX™ TC HDL GLU
• 00893038002913: Cholestech LDX™ Lipid Profile
• 00893038002906: Cholestech LDX™ TC GLU
• 00893038002890: Cholestech LDX™ TC HDL
• 00893038002883: Cholestech LDX™ TC
• 00810039380512: Cholestech LDX™ Analyzer
• 00810039380307: Cholestech LDX™ Analyzer