Urea Nitrogen Reagent Set 501-404

GUDID 00812137011916

For the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. Determination of urea nitrogen in serum is widely used as a screening test for renal function. When used in conjunction with the determination of creatinine in serum it is helpful in the differential diagnosis of the three types of azotemia; pre-renal, renal and post-renal.

CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Urea IVD, kit, enzyme spectrophotometry

• Primary Device ID: 00812137011916
• NIH Device Record Key: cd02d486-6d52-4069-838f-b22f3c491a63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Urea Nitrogen Reagent Set
• Version Model Number: R1 x 500mL, R2 x 125mL
• Catalog Number: 501-404
• Company DUNS: 048144997
• Company Name: CLINICAL DIAGNOSTIC SOLUTIONS, INC.
• Device Count: 2
• 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	00812137011916 [Primary]
GS1	00812137012272 [Unit of Use]

FDA Product Code

• CDQ: Urease And Glutamic Dehydrogenase, Urea Nitrogen

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: 2018-04-17
• Device Publish Date: 2016-10-12

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