ClearChem Diagnostics Inc. Creatine Kinase (CK)

Basic Information

• Brand Name: ClearChem Diagnostics Inc. Creatine Kinase (CK)
• Primary DI: 00852169008089
• Version / Model: CPK1110
• Catalog Number: CPK1110
• Company Name: CLEARCHEM DIAGNOSTICS INC.
• Labeler DUNS: 010655581
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-30
• Public Version: 1
• Public Version Date: 2018-05-31
• Public Version Status: New
• Public Device Record Key: cbc2a7e9-2802-4757-93ec-38f70eb09a5a

Device Description

In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL

Device Characteristics

• Single Use: Yes
• 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
CGS	NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES	Clinical Chemistry	862.1215	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53006	Total creatine kinase (CK) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total creatine kinase (CK) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852169008089	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	225	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Refrigerated