FDA.reportPublic FDA data

LIFECODES HLA-DRB1 eRES SSO Typing Kit for use with Luminex

Primary DI
10888234400073
Brand
LIFECODES HLA-DRB1 eRES SSO Typing Kit for use with Luminex
Company
IMMUCOR GTI DIAGNOSTICS, INC.
Model
628925
Catalog number
628925
Device description
DNA Typing of Class II HLA alleles, to aid in transfusion and transplantation donor and recipient matching
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1300750

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1300750

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888234400073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088823440007310888234400073

GMDN Terms#

Term, Definition table
TermDefinition
DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose or predict donor and recipient tissue compatibility based on one or multiple genetic markers from the major histocompatibility complex (MHC) family of genes, using a nucleic acid technique (NAT). Genetic markers may include HLA-A, HLA-B, HLA-C, DRB1, DRB3, DRB4, DRB5, DQB1, DPB1, MICA and/or C4.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away From Light
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-466-8267LIFECODES@immucor.com
855-466-8267info@immucor.com

Regulatory Flags#

DUNS number
606034197
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888234500858MatchX8886288886282025-09-30
10888234500827Dilution Solution628515UDI628515UDI2020-05-20
10888234500841LIFECODES LifeScreen XP6282206282202023-07-11
10888234400332LIFECODES LSA Class I 265100IVD265100IVD2022-04-06
10888234400349LIFECODES LSA Class II 265200IVD265200IVD2022-04-06
10888234500810LIFECODES MATCH IT! Antibody Software8886278886272022-02-18
10888234500803LIFECODES MATCH IT!™ DNA Software v1.38886238886232020-02-26
10888234400011LIFECODES HLA-A eRES SSO Typing Kit for use with Luminex6289136289132016-09-15
10888234400035LIFECODES HLA-B eRES SSO Typing Kit for use with Luminex6289176289172016-09-15
10888234400059LIFECODES HLA-C eRES SSO Typing Kit for use with Luminex6289216289212016-09-15
10888234400080LIFECODES HLA-DRB 3,4,5 SSO Typing Kit for use with Luminex6289276289272016-09-15
10888234400134LIFECODES TAQ Polymerase6280756280752016-09-15
10888234400295LIFECODES Class I ID Typing Kit for use with Luminex6282006282002016-09-15
10888234400301LIFECODES Class II IDv2 for use with Luminex6282236282232016-09-15
10888234400318LIFECODES LifeScreen Deluxe6282156282152016-09-15
10888234400462LIFECODES HLA-DQA1/B1 SSO Typing Kit for use with Luminex6289306289302016-09-15
10888234400479LIFECODES HLA-DPA1/B1 SSO Typing Kit for use with Luminex6289366289362016-09-15
10888234400509Conjugate Concentrate6282126282122016-09-15
10888234400516LIFECODES Wash Buffer6282116282112016-09-15
10888234400561Conjugate Concentrate6282016282012016-09-15

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
00812117010199LABScreen™ Single Antigen HLA Class I ExPlexONE LAMBDA, INC.MZI2020-06-03
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
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