HDL Cholesterol Reagent Set 501-419

GUDID 00812137012067

The HDL-Cholesterol Reagent Set is intended for the in vitro quantitative determination of High Density Lipoprotein Cholesterol in human serum or plasma. The reagent can assist in the diagnosis and treatment of patients at risk for developing coronary heart disease.

CLINICAL DIAGNOSTIC SOLUTIONS, INC.

High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent

• Primary Device ID: 00812137012067
• NIH Device Record Key: 7f3da08e-56a2-47b0-acd4-86913cc1afbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HDL Cholesterol Reagent Set
• Version Model Number: R1 x 2 x 70mL, R2 x 1 x 50mL
• Catalog Number: 501-419
• 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	00812137012067 [Primary]
GS1	00812137012319 [Unit of Use]

FDA Product Code

• LBS: Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, 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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