Beckman Coulter® PK® Systems Control

Basic Information

• Brand Name: Beckman Coulter® PK® Systems Control
• Primary DI: 23661562173178
• Version / Model: 17317
• Catalog Number: 17317
• Company Name: DIAGAST
• Labeler DUNS: 381527001
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-01-12
• Public Version: 6
• Public Version Date: 2023-06-09
• Public Version Status: Update
• Public Device Record Key: ecbada22-286e-4b0b-b918-4202d8af06ab

Device Description

Blood Grouping Reagent Control, formulated for Automated Systems, Beckman Coulter® PK® System

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• 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
KSF	Kit, Quality Control For Blood Banking Reagents	Hematology	864.9650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52705	Antisera matrix (non-reactive) IVD, control	A material consisting of antisera matrix but containing no active immunoglobulins that is intended be used as a negative control to verify the performance of an assay when testing a clinical specimen for red blood cell antigens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	23661562173178	GS1
Unit of Use	13661562173171	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
BK060024	0
BK190313	0

Storage Conditions

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