FDA.reportPublic FDA data

SeCore™ CDx HLA GSSP Kit

Primary DI
00812117016825
Brand
SeCore™ CDx HLA GSSP Kit
Company
ONE LAMBDA, INC.
Model
SECCDX-GSSP
Catalog number
SECCDX-GSSP
Device description
The SeCore CDx HLA Sequencing System is an in-vitro diagnostic intended to be used as a companion diagnostic for the qualitative detection of HLA alleles to aid in the selection of patients to receive specific medicinal products.
Published
2023-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QUKHuman Leukocyte Antigen (Hla) Typing Companion Diagnostic Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUKHuman Leukocyte Antigen (Hla) Typing Companion Diagnostic TestImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812117016825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812117016825008121170168258121170168250812117016825

GMDN Terms#

Term, Definition table
TermDefinition
HLA class I & II antigen tissue typing IVD, kit, multiplexA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple HLA class I and II antigens in a clinical specimen, using a multiplex method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-30 Degrees Celsius-10 Degrees Celsius

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
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
00812117010199LABScreen™ Single Antigen HLA Class I ExPlexN/ALS1AEX012020-06-03
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
00812117016818SeCore™ CDx HLA A Locus Sequencing KitONE LAMBDA, INC.QUK2023-01-30
00812117016849uTYPE™ CDx HLA Sequence Analysis SoftwareONE LAMBDA, INC.QUK2023-01-30