Creatine Kinase Assay

Basic Information

• Brand Name: Creatine Kinase Assay
• Primary DI: 00628063401079
• Version / Model: SK326-20
• Catalog Number: SK326-20
• Company Name: SEKISUI DIAGNOSTICS, LLC
• Labeler DUNS: 966812344
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-24
• Public Version: 1
• Public Version Date: 2018-10-25
• Public Version Status: New
• Public Device Record Key: 00b0669e-d209-40aa-a828-6d29a556e893

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• 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
53001	Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of total creatine kinase (CK) in a clinical specimen, using an enzyme spectrophotometry method.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00628063401079	GS1

Premarket Submissions

Submission Number	Supplement Number
K973999	000