CellSearch

Basic Information

• Brand Name: CellSearch
• Primary DI: 10888385000023
• Version / Model: 7900003
• Catalog Number: 7900003
• Company Name: MENARINI SILICON BIOSYSTEMS, INC.
• Labeler DUNS: 057722858
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 3
• Public Version Date: 2019-02-07
• Public Version Status: Update
• Public Device Record Key: 72130eb1-fb81-4f63-ac10-8bbc087b114c

Device Description

Circulating Tumor Cell Control Cell Kit

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: Yes
• 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
NRS	CONTROL MATERIAL, BLOOD CIRCULATING EPITHELIAL CANCER CELL	Hematology	864.8625	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56919	Multiple CD cell marker IVD, control	A material which is used to verify the performance of an assay 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888385000023	GS1
Unit of Use	80888385000022	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Protect reagents from exposure to bright sunlight
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius