FDA.reportPublic FDA data

LABScreen™ Single Antigen HLA Class I ExPlex

Primary DI
00812117010199
Brand
LABScreen™ Single Antigen HLA Class I ExPlex
Company
ONE LAMBDA, INC.
Model
N/A
Catalog number
LS1AEX01
Device description
LABScreen products are intended for use in detection of HLA antibody using flow cytometric technology
Published
2020-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MZITest, Qualitative, For Hla, Non-Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZITest, Qualitative, For Hla, Non-DiagnosticUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812117010199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812117010199008121170101998121170101990812117010199

GMDN Terms#

Term, Definition table
TermDefinition
HLA class I & II antibody screening IVD, kit, multiplexA collection of reagents and other associated materials intended to be used in screening for one or multiple antibodies to HLA class I and II antigens in a clinical specimen, using solid phase antigens together with a multiplex method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.822.88241lambda-TechSupport@thermofisher.com

Regulatory Flags#

DUNS number
118289289
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812117016818SeCore™ CDx HLA A Locus Sequencing KitSECCDX-ASECCDX-A2023-01-30
00812117016825SeCore™ CDx HLA GSSP KitSECCDX-GSSPSECCDX-GSSP2023-01-30
00812117016849uTYPE™ CDx HLA Sequence Analysis SoftwareUTPCDX-PGRUTPCDX-PGR2023-01-30
00814695024452Micro SSP™ Gel System - 108 WellsN/AMGS1082018-06-15
00812117015484PE-Conjugated StreptavidinN/ALSPSAB22020-06-04
00812117014654LABScreen™ Single Antigen HLA Class II ExPlexN/ALS2AEX012020-06-03
00814695022496UniMatch™ Plus Software N/A7901112016-08-31
00812117015255Adsorb OutN/AADSORB2018-06-15
00812117015873Fluorobeads™ T Lymphocyte – 25 Isolations N/AFB1-252018-05-31
00812117015880Fluorobeads™ B Lymphocyte – 25 IsolationsN/AFB2-252018-05-31
00812117015897FluoroQuench Acridine Orange/Ethidium Bromide - 100mlN/AFQAE1002018-05-31
00812117016184FluoroQuench Acridine Orange/Ethidium Bromide - 500mlN/AFQAE5002018-05-31
00812117016207FluoroQuench Acridine Orange/Ethidium Bromide - 2000 mlN/AFQAE20002018-05-31
00812117016832Lympho-Kwik T/B Lymphocyte, 25 isolationsN/ALKTB252018-05-31
00812117018041Fluorobeads™ T Lymphocyte – 100 Isolations N/AFB1-1002018-05-31
00812117018058FluoroBeads™ T Developer (10X)N/AFB1-DEV2018-05-31
00812117018072Fluorobeads™ B Lymphocyte – 100 IsolationsN/AFB2-1002018-05-31
00812117018447FluoroQuench Plus Acridine Orange/Ethidium Bromide - 100 mlN/AFQZAE1002018-05-31
00812117018768Lympho-Kwik Mononuclear Cell, 50 isolationsN/ALK-50-MN2018-05-31
00812117018775Lympho-Kwik T Lymphocyte, 50 isolationsN/ALK-50-T2018-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888234500858MatchXIMMUCOR GTI DIAGNOSTICS, INC.MZI2025-09-30
10888234500841LIFECODES LifeScreen XPIMMUCOR GTI DIAGNOSTICS, INC.MZI2023-07-11
10888234400332LIFECODES LSA Class I IMMUCOR GTI DIAGNOSTICS, INC.MZI2022-04-06
10888234400349LIFECODES LSA Class II IMMUCOR GTI DIAGNOSTICS, INC.MZI2022-04-06
10888234500810LIFECODES MATCH IT! Antibody SoftwareIMMUCOR GTI DIAGNOSTICS, INC.MZI2022-02-18
00382906434388N/ABECTON, DICKINSON AND COMPANYMZI2021-01-19
00382906579874N/ABECTON, DICKINSON AND COMPANYMZI2021-01-07
00382906407764N/ABECTON, DICKINSON AND COMPANYMZI2020-12-17
00382903401833N/ABecton, Dickinson And CompanyMZI2020-12-01
00812117015484PE-Conjugated StreptavidinONE LAMBDA, INC.MZI2020-06-04
00812117014654LABScreen™ Single Antigen HLA Class II ExPlexONE LAMBDA, INC.MZI2020-06-03
10888234500827Dilution SolutionIMMUCOR GTI DIAGNOSTICS, INC.MZI2020-05-20
10888234500803LIFECODES MATCH IT!™ DNA Software v1.3IMMUCOR GTI DIAGNOSTICS, INC.MZI2020-02-26
07611969965700Lymphoscreen ABC-60Bio-Rad Medical Diagnostics GmbHMZI2018-03-08
07611969965717Lymphoscreen DR 30x2Bio-Rad Medical Diagnostics GmbHMZI2018-03-08
10888234400011LIFECODES HLA-A eRES SSO Typing Kit for use with LuminexIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400028LIFECODES HLA-B SSO Typing Kit for use with LuminexIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400035LIFECODES HLA-B eRES SSO Typing Kit for use with LuminexIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400059LIFECODES HLA-C eRES SSO Typing Kit for use with LuminexIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400066LIFECODES HLA-DRB1 SSO Typing Kit for use with LumineIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400073LIFECODES HLA-DRB1 eRES SSO Typing Kit for use with LuminexIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400080LIFECODES HLA-DRB 3,4,5 SSO Typing Kit for use with LuminexIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400134LIFECODES TAQ PolymeraseIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400295LIFECODES Class I ID Typing Kit for use with LuminexIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400301LIFECODES Class II IDv2 for use with LuminexIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400318LIFECODES LifeScreen DeluxeIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400394LIFECODES MATCH IT!™ DNA Software v1.2IMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400462LIFECODES HLA-DQA1/B1 SSO Typing Kit for use with LuminexIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400479LIFECODES HLA-DPA1/B1 SSO Typing Kit for use with LuminexIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15
10888234400509Conjugate ConcentrateIMMUCOR GTI DIAGNOSTICS, INC.MZI2016-09-15