CELL-DYN

Basic Information

• Brand Name: CELL-DYN
• Primary DI: 00380740135713
• Version / Model: 01H77-02
• Catalog Number: 01H7702
• Company Name: ABBOTT LABORATORIES
• Labeler DUNS: 079226220
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 4e4a02ab-7f6b-4eac-86ff-4b674901a73f

Device Description

CELL-DYN Sapphire System WBC REAGENT - PART A

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: Yes
• 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
GGK	PRODUCTS, RED-CELL LYSING PRODUCTS	Hematology	864.8540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
55858	White blood cell count IVD, kit, cell count	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of the white blood cell (leukocyte) count and/or the differential of white cell types in a clinical specimen using a manual, semi-automated or automated cell count method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00380740001131	GS1	Case	4	In Commercial Distribution
Primary	00380740135713	GS1

Customer Contacts

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