Primary Device ID | 00812117011370 |
NIH Device Record Key | 11f86fa6-f619-4e24-8b4b-f7d423d178c4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FlowPRA™ Single Antigen HLA Class I - 4 Antibody Detection Test |
Version Model Number | N/A |
Catalog Number | FL1HD04 |
Company DUNS | 118289289 |
Company Name | ONE LAMBDA, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 |
Phone | 800.822.8824 |
techsupport@onelambda.com | |
Phone | 800.822.8824 |
techsupport@onelambda.com |
Storage Environment Temperature | Between -80 Degrees Celsius and -65 Degrees Celsius |
Storage Environment Temperature | Between -80 Degrees Celsius and -65 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00812117011370 [Primary] |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-08-11 |
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 | 2018-07-02 FluoroBeads-B provide a simple procedure for the isolation of B lymphocytes for use in HLA Class II typing assays using fluoresc |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() FLOWPRA 75516225 2584188 Live/Registered |
One Lambda, Inc. 1998-07-09 |