PK7400

Basic Information

• Brand Name: PK7400
• Primary DI: 14987666543344
• Version / Model: B53299
• Company Name: Beckman Coulter, Inc.
• Labeler DUNS: 008254708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-06
• Public Version: 2
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: 4b8beca2-2253-4cc6-8dda-aa7412396bff

Device Description

PK7400 Automated Microplate System

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	864.9175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56714	Blood group/antibody screening analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used to perform pre-transfusion blood group testing, red cell antibody screening/identification and/or red cell phenotyping of clinical specimens or donor specimens in order to determine suitability for transfusion or transplantation. Testing may include ABO, Rhesus or other red cell blood group systems and may use microplate-based serological methods, cassettes or column agglutinating technology.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	14987666543344	GS1

Premarket Submissions

Submission Number	Supplement Number
BK180292	0