FDA.reportPublic FDA data

DonorScreen-HLA® Class I and Class II

Primary DI
10888234500193
Brand
DonorScreen-HLA® Class I and Class II
Company
IMMUCOR GTI DIAGNOSTICS, INC.
Model
DSI+II
Catalog number
DSI+II
Device description
DonorScreen-HLA Class I and Class II assay is a qualitative Enzyme Linked Immunosorbent Assay (ELISA) for use on the Bio-Rad QuickStep instrument. DonorScreen-HLA Class I and Class II assay ELISA is designed to detect anti-HLA class I and class II antibodies in human serum or plasma of blood donors.
Published
2016-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
BK0700450

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0700450

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888234500193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088823450019310888234500193

GMDN Terms#

Term, Definition table
TermDefinition
HLA class I & II antibody screening IVD, kit, enzyme immunoassay (EIA)A 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 an enzyme (EIA) immunoassay 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
855-466-8267waukeshatechsupport@immucor.co
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00613745003948ONtrack AmpGenBioMZI2026-06-08
00613745003955ONtrack PrepGenBioMZI2026-06-08
00613745003962HISTO SPOT ® HLA AB Reagent KitGenBioMZI2026-06-08
00613745003979HISTO SPOT ® HLA AB ID CLASS II – AD1GenBioMZI2026-06-08
00613745003986HISTO SPOT ® HLA AB ID CLASS IIGenBioMZI2026-06-08
00613745003993HISTO SPOT ® HLA AB ID CLASS IGenBioMZI2026-06-08
00613745003931NGSgo-AmpX v3 HLA-DRB3/4/5 (96)GenBioMZI2026-05-15
00613745003870NGSgo®-AmpX v2 EnhancerGenBioMZI2026-05-06
00613745003887NGSgo®-LibrX End Prep EnzymeGenBioMZI2026-05-06
00613745003894NGSgo®-LibrX End Prep BufferGenBioMZI2026-05-06
00613745003900NGSgo®-LibrX Ligase MixGenBioMZI2026-05-06
00613745003917NGSgo®-LibrX Ligation EnhancerGenBioMZI2026-05-06
00613745003924GenDx-LongMixGenBioMZI2026-05-06
00613745003863NGSgo®-AmpX v2GenBioMZI2026-03-30
00613745002446GenDx-LongMixGenBioMZI2025-12-27
00613745002453Nuclease-Free WaterGenBioMZI2025-12-27
00613745002491NGSgo-IndX Plate IIIGenBioMZI2025-12-27
00613745002576NGSgo-IndX Plate IIGenBioMZI2025-12-27
00613745002705 NGSgo-IndX Plate I (Indices Illumina)GenBioMZI2025-12-27
00613745003443NGSgo-IndX Illumina Adapter & Indices plate I (96) GenBioMZI2025-12-27
00613745003450NGSgo-IndX Illumina Adapter & Indices plate II (96) GenBioMZI2025-12-27
00613745003474NGSgo-IndX Illumina Adapter & Indices plate IV (96) GenBioMZI2025-12-27
00613745003481GenDx-AMPure XP - AMPure beads and elution buffer (5 ml) GenBioMZI2025-12-27
00613745003689NGS-Turbo® demo workflow reagentsGenBioMZI2025-12-27
00613745003702NGSgo® Pronto demo Workflow reagentsGenBioMZI2025-12-27
00613745003719NGSgo® Pronto demo Wash reagentsGenBioMZI2025-12-27
00613745001630NGSgo Library Full Kit for Illumina IndX Plate IIIGenBioMZI2025-12-26
00613745002293NGSgo Library Full Kit for Illumina IndX Plate IVGenBioMZI2025-12-26
00613745002309 NGSgo-AmpX v2 HLA GeneSuiteGenBioMZI2025-12-26
00613745002316NGSgo Library Full Kit for Illumina IndX Plate IGenBioMZI2025-12-26