Albumin Reagent 501-397

GUDID 00812137011848

For the quantitative determination of Albumin in serum.

CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Albumin IVD, reagent

• Primary Device ID: 00812137011848
• NIH Device Record Key: 0bf2ebed-8f09-485c-80e8-c4e2c23644eb
• Commercial Distribution Discontinuation: 2019-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Albumin Reagent
• Version Model Number: 500 mL
• Catalog Number: 501-397
• Company DUNS: 048144997
• Company Name: CLINICAL DIAGNOSTIC SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: true
• 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: 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 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812137011848 [Primary]

FDA Product Code

• CIX: Bromcresol Green Dye-Binding, Albumin

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

On-Brand Devices [Albumin Reagent]

• 00081213701184: For the quantitative determination of Albumin in serum.
• 00812137011848: For the quantitative determination of Albumin in serum.