Fluorobeads™ B Lymphocyte – 25 Isolations FB2-25

GUDID 00812117015880

FluoroBeads-B provide a simple procedure for the isolation of B lymphocytes for use in HLA Class II typing assays using fluorescent dyes. PBS/Citrate is a reagent for use in the FluoroBeads-B isolation method.

ONE LAMBDA, INC.

Cell centrifugation/density gradient separation reagent IVD

• Primary Device ID: 00812117015880
• NIH Device Record Key: 971befda-b631-4355-bb3b-df8e647c5487
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fluorobeads™ B Lymphocyte – 25 Isolations
• Version Model Number: N/A
• Catalog Number: FB2-25
• Company DUNS: 118289289
• Company Name: ONE LAMBDA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800.822.8824
• Email: 1lambda-TechSupport@thermofisher.com
• Phone: 800.822.8824
• Email: 1lambda-TechSupport@thermofisher.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 5 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 5 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812117015880 [Primary]

FDA Product Code

• JCF: Lymphocyte Separation Medium

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-02
• Device Publish Date: 2018-05-31

Devices Manufactured by ONE LAMBDA, INC.

• 00812117015484 - PE-Conjugated Streptavidin: 2020-06-12 For use in the detection of biotinylated proteins and nucleic acids in biotinylated proteins and nucleic acids in LABType™ SSO
• 00812117010199 - LABScreen™ Single Antigen HLA Class I ExPlex: 2020-06-11 LABScreen products are intended for use in detection of HLA antibody using flow cytometric technology
• 00812117014654 - LABScreen™ Single Antigen HLA Class II ExPlex: 2020-06-11 LABScreen products are intended for use in detection of HLA antibody using flow cytometric technology
• 00814695022496 - UniMatch™ Plus Software: 2019-01-23 UniMatch PLUS Software analyzes the reaction patterns of UniTray™ and AllSet+™ Gold kits for the determination of Human Leuk
• 00812117015255 - Adsorb Out: 2018-07-16 To reduce high background that is caused by nonspecific binding of materials in human sera to the latex beads used in flow antib
• 00814695024452 - Micro SSP™ Gel System - 108 Wells: 2018-07-16 The Micro SSP Gel Box System is a compact gel box for electrophoresis.
• 00812117015873 - Fluorobeads™ T Lymphocyte – 25 Isolations: 2018-07-02 FluoroBeads-T provide a simple procedure for the isolation of T lymphocytes for use in microcytotoxicity assays using fluorescen
• 00812117015880 - Fluorobeads™ B Lymphocyte – 25 Isolations: 2018-07-02FluoroBeads-B provide a simple procedure for the isolation of B lymphocytes for use in HLA Class II typing assays using fluorescent dyes. PBS/Citrate is a reagent for use in the FluoroBeads-B isolation method.
• 00812117015880 - Fluorobeads™ B Lymphocyte – 25 Isolations: 2018-07-02 FluoroBeads-B provide a simple procedure for the isolation of B lymphocytes for use in HLA Class II typing assays using fluoresc