FDA.reportPublic FDA data

LIFECODES Class I ID Typing Kit for use with Luminex

Primary DI
10888234400295
Brand
LIFECODES Class I ID Typing Kit for use with Luminex
Company
IMMUCOR GTI DIAGNOSTICS, INC.
Model
628200
Catalog number
628200
Device description
LIFECODES Class I ID is a bead-based immunoassay used to qualitatively detect Panel Reactive HLA IgG antibodies (PRA)
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
BK0400350

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0400350

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888234400295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088823440029510888234400295

GMDN Terms#

Term, Definition table
TermDefinition
HLA class I 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 antigens in a clinical specimen, using a multiplex method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
10888234400073LIFECODES HLA-DRB1 eRES SSO Typing Kit for use with Luminex6289256289252016-09-15
10888234400080LIFECODES HLA-DRB 3,4,5 SSO Typing Kit for use with Luminex6289276289272016-09-15
10888234400134LIFECODES TAQ Polymerase6280756280752016-09-15
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
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
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