LABScreen™ Mixed Class I & II LSM12

GUDID 00812117011592

LABScreen products are intended for use in detection of HLA antibody using flowcytometric technology

ONE LAMBDA, INC.

HLA class I & II antibody screening IVD, kit, multiplex
Primary Device ID00812117011592
NIH Device Record Key2cca5caf-8bff-4e09-9797-88d7488bf483
Commercial Distribution StatusIn Commercial Distribution
Brand NameLABScreen™ Mixed Class I & II
Version Model NumberN/A
Catalog NumberLSM12
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 -65 Degrees Celsius and -65 Degrees Celsius
Storage Environment TemperatureBetween -65 Degrees Celsius and -65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100812117011592 [Primary]

FDA Product Code

MZITest,Qualitative,For Hla,Non-Diagnostic

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.

00812117015484 - PE-Conjugated Streptavidin2020-06-12 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 ExPlex2020-06-11 LABScreen products are intended for use in detection of HLA antibody using flow cytometric technology
00812117014654 - LABScreen™ Single Antigen HLA Class II ExPlex2020-06-11 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 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
00812117015880 - Fluorobeads™ B Lymphocyte – 25 Isolations2018-07-02 FluoroBeads-B provide a simple procedure for the isolation of B lymphocytes for use in HLA Class II typing assays using fluoresc

Trademark Results [LABScreen]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LABSCREEN
LABSCREEN
76511791 not registered Dead/Abandoned
ONE LAMBDA, INC.
2003-04-17
LABSCREEN
LABSCREEN
76372186 2730892 Live/Registered
ONE LAMBDA, INC.
2002-02-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.