Pointe Creatinine for BS480

Basic Information

• Brand Name: Pointe Creatinine for BS480
• Primary DI: 00811727015808
• Version / Model: 14-C7539-432
• Catalog Number: 14-C7539-432
• Company Name: POINTE SCIENTIFIC, INC.
• Labeler DUNS: 045623154
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-28
• Public Version: 2
• Public Version Date: 2022-12-20
• Public Version Status: Update
• Public Device Record Key: 1ed6bd56-8a84-428c-94f6-ee73d2392200

Device Description

Pointe Creatinine reagent packaged for use on the BS480 analyzer. 6x60mL, 6x12mL Kit. For the quantitative determination of creatinine 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
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	00811727015808	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K830556	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius