FlowPRA™ Single Antigen HLA Class II - 4 Antibody Detection Test FL2HD04

GUDID 00812117011486

The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.

ONE LAMBDA, INC.

HLA class I & II antibody screening IVD, kit, multiplex HLA class I & II antibody screening IVD, kit, multiplex
Primary Device ID00812117011486
NIH Device Record Keya7b99892-9747-43a6-9e1a-9b44e83d4dfa
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlowPRA™ Single Antigen HLA Class II - 4 Antibody Detection Test
Version Model NumberN/A
Catalog NumberFL2HD04
Company DUNS118289289
Company NameONE LAMBDA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
Emailtechsupport@onelambda.com
Phone800.822.8824
Emailtechsupport@onelambda.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -80 Degrees Celsius and -65 Degrees Celsius
Storage Environment TemperatureBetween -80 Degrees Celsius and -65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100812117011486 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-11

Devices Manufactured by ONE LAMBDA, INC.

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00812117015255 - Adsorb Out2018-07-16 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 Wells2018-07-16 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
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Trademark Results [FlowPRA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FLOWPRA
FLOWPRA
75516225 2584188 Live/Registered
One Lambda, Inc.
1998-07-09

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