Creatinine Reagent Set 501-409

GUDID 00812137011961

For the quantitative determination of creatinine in serum. For in vitro diagnostic use only. Creatinine assays are most frequently performed to aid in the determination of renal function.

CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Creatinine IVD, reagent Creatinine IVD, reagent

• Primary Device ID: 00812137011961
• NIH Device Record Key: 17db1303-4daa-4f77-a571-97e6ea798f83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Creatinine Reagent Set
• Version Model Number: R1 x 500mL, R2 x 125mL
• Catalog Number: 501-409
• 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 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812137011961 [Primary]
GS1	00812137012296 [Unit of Use]

FDA Product Code

• CGX: Alkaline Picrate, Colorimetry, Creatinine

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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