Fluorobeads™ B Lymphocyte – 100 Isolations FB2-100

GUDID 00812117018072

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: 00812117018072
• NIH Device Record Key: 08c4c7ff-5a13-48e5-973d-d52b4c3e6a21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fluorobeads™ B Lymphocyte – 100 Isolations
• Version Model Number: N/A
• Catalog Number: FB2-100
• 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	00812117018072 [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

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