POINTE SCIENTIFIC CK-MB

Basic Information

• Brand Name: POINTE SCIENTIFIC CK-MB
• Primary DI: 00811727010940
• Version / Model: C7562-26
• Catalog Number: C7562-26
• Company Name: POINTE SCIENTIFIC, INC.
• Labeler DUNS: 045623154
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 4
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 8e7d4f1e-67f8-4b8f-a50b-68161b3318a4

Device Description

The CK-MB Reagent is for the quantitative determination of the isoenzyme Creatine Kinase-MB (CK-MB) in serum. For in vitro diagnostic use only.

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
JHW	U.V. Method, Cpk Isoenzymes	Clinical Chemistry	862.1215	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52994	Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of creatine kinase myocardial isoenzyme (CKMB) in a clinical specimen, using a spectrophotometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00811727010940	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K942958	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius