Triglycerides Reagent 501-417

GUDID 00001812701208

For the in vitro quantitative determination of Triglycerides in serum or plasma. Triglycerides determinations are of interest in the diagnosis and treatment of atherosclerosis, poorly controlled diabetes mellitus, nephrosis, liver disease, or other diseases involving lipid metabolism.

CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Triglyceride IVD, reagent

• Primary Device ID: 00001812701208
• NIH Device Record Key: 3aecc73b-3d4a-42ab-bbf0-2b421a6ea188
• Commercial Distribution Discontinuation: 2019-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Triglycerides Reagent
• Version Model Number: 500mL
• Catalog Number: 501-417
• Company DUNS: 048144997
• Company Name: CLINICAL DIAGNOSTIC SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8004533328
• Email: quality@cdsolinc.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00001812701208 [Primary]

FDA Product Code

• CDT: Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-31
• Device Publish Date: 2016-10-12

Devices Manufactured by CLINICAL DIAGNOSTIC SOLUTIONS, INC.

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• 00001812701208 - Triglycerides Reagent: 2020-03-31 For the in vitro quantitative determination of Triglycerides in serum or plasma. Triglycerides determinations are of interest in
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