Creatinine Reagent Set

Basic Information

• Brand Name: Creatinine Reagent Set
• Primary DI: 00812137011961
• Version / Model: R1 x 500mL, R2 x 125mL
• Catalog Number: 501-409
• Company Name: CLINICAL DIAGNOSTIC SOLUTIONS, INC.
• Labeler DUNS: 048144997
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-10-12
• Public Version: 3
• Public Version Date: 2022-12-20
• Public Version Status: Update
• Public Device Record Key: 17db1303-4daa-4f77-a571-97e6ea798f83

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	862.1225	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53252	Creatinine IVD, reagent	A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of creatinine in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812137011961	GS1
Unit of Use	00812137012296	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius