Fluorobeads™ T Lymphocyte – 100 Isolations

Basic Information

• Brand Name: Fluorobeads™ T Lymphocyte – 100 Isolations
• Primary DI: 00812117018041
• Version / Model: N/A
• Catalog Number: FB1-100
• Company Name: ONE LAMBDA, INC.
• Labeler DUNS: 118289289
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-31
• Public Version: 1
• Public Version Date: 2018-07-02
• Public Version Status: New
• Public Device Record Key: 1ae837ef-9860-4efb-869c-5d4a8e5024f6

Device Description

FluoroBeads-T provide a simple procedure for the isolation of T lymphocytes for use in microcytotoxicity assays using fluorescent dyes. FluoroBeads-T Developer is specifically designed to be used in the FluoroBeads-T isolation method.

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
JCF	Lymphocyte Separation Medium	Hematology	864.8500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41427	Cell centrifugation/density gradient separation reagent IVD	A substance or reactant intended to be used for the isolation of cells from a clinical specimen (e.g., lymphocytes from whole blood, cells from a liquid-based cytology specimen) using centrifugation and density gradient to achieve specimen component separation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812117018041	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 5 Degrees Celsius