CELL-DYN

Basic Information

• Brand Name: CELL-DYN
• Primary DI: 00380740005115
• Version / Model: 03H62-01
• Catalog Number: 03H6201
• Company Name: ABBOTT LABORATORIES
• Labeler DUNS: 079226220
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-06
• Public Version: 3
• Public Version Date: 2022-06-28
• Public Version Status: Update
• Public Device Record Key: 1672b7f5-d597-4bb5-b748-c6b34a5555be
• Distribution End Date: 2022-03-31

Device Description

CELL-DYN 3700 System CN-FREE HGB / WIC LYSE

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
61165	Blood cell lysis reagent IVD	A substance or reactant intended to be used alone or in combination with other IVDs to disrupt the cell membrane of blood cells [red blood cells (RBCs), white blood cells (WBCs) and/or platelets] to release cytoplasmic contents in preparation for further analysis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740005115	GS1

Customer Contacts

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