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 ID00812117018072
NIH Device Record Key08c4c7ff-5a13-48e5-973d-d52b4c3e6a21
Commercial Distribution StatusIn Commercial Distribution
Brand NameFluorobeads™ B Lymphocyte – 100 Isolations
Version Model NumberN/A
Catalog NumberFB2-100
Company DUNS118289289
Company NameONE LAMBDA, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800.822.8824
Email1lambda-TechSupport@thermofisher.com
Phone800.822.8824
Email1lambda-TechSupport@thermofisher.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 5 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 5 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100812117018072 [Primary]

FDA Product Code

JCFLymphocyte Separation Medium

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-02
Device Publish Date2018-05-31

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Trademark Results [Fluorobeads]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FLUOROBEADS
FLUOROBEADS
74006603 1611015 Live/Registered
ONE LAMBDA, INC.
1989-12-01

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