COULTER ReticPrep

Basic Information

• Brand Name: COULTER ReticPrep
• Primary DI: 15099590221126
• Version / Model: 7546978
• Catalog Number: 7546978
• Company Name: Beckman Coulter, Inc.
• Labeler DUNS: 008254708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2023-06-19
• Public Version Status: Update
• Public Device Record Key: 171fd8ae-96f9-4a95-8968-c43b7341f86f

Device Description

COULTER ReticPrep Reagent Kit

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
GKZ	Counter, Differential Cell	Hematology	864.5220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55863	Reticulocyte count IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of reticulocyte red blood cells in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15099590221126	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 16 – 30 Degrees Celsius