N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00382903445639
• Version / Model: 344563
• Catalog Number: 344563
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 024230633
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-08
• Public Version: 10
• Public Version Date: 2023-10-09
• Public Version Status: Update
• Public Device Record Key: ba7d2338-7859-42f2-860b-e5ce0932aef6

Device Description

BD® Stem Cell Enumeration Kit

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
GKZ	Counter, differential cell	Hematology	864.5220	2
OYE	Flow cytometric reagents and accessories.	Hematology	864.5220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56916	Multiple CD cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple cluster of differentiation (CD) cell markers in a clinical specimen, including associated percentage and/or enumeration of specific cell populations, using a fluorescent activated cell sorting/flow cytometry (FACS/Flow) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00382903445639	GS1

Customer Contacts

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

Storage Conditions

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