LDL Cholesterol Reagent Set 501-420

GUDID 00812137012074

The LDL-Cholesterol Reagent Set is intended for the in vitro quantitative determination of Low Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. Elevated LDL cholesterol is the primary target of cholesterol-lowering therapy.

CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Dense low density lipoprotein (DLDL) cholesterol IVD, kit, mass spectrometry

• Primary Device ID: 00812137012074
• NIH Device Record Key: e589da2e-e125-48e0-add2-f8e08c9d7678
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LDL Cholesterol Reagent Set
• Version Model Number: R1 x 2 x 70mL, R2 x 1 x 50mL
• Catalog Number: 501-420
• Company DUNS: 048144997
• Company Name: CLINICAL DIAGNOSTIC SOLUTIONS, INC.
• Device Count: 3
• DM Exempt: true
• 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: 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
• Phone: 8004533328
• Email: quality@cdsolinc.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812137012074 [Primary]
GS1	00812137012340 [Unit of Use]

FDA Product Code

• LBR: Ldl & Vldl Precipitation, Hdl

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: 2016-10-12

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