FDA.reportPublic FDA data

Concentrated Wash (10X)

Primary DI
10888234500407
Brand
Concentrated Wash (10X)
Company
IMMUCOR GTI DIAGNOSTICS, INC.
Model
403622
Catalog number
403622
Device description
For Use with Factor VIII Antibody Screen and PakPlus
Published
2016-07-08
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
MYPTest,Platelet Antibody

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYPTest, Platelet AntibodyUnknown2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK9600590

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK9600590

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888234500407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088823450040710888234500407

GMDN Terms#

Term, Definition table
TermDefinition
Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used in screening and/or identification of one or multiple antibodies to human platelet antigen (HPA) systems, which may include HPA-1, HPA-2, HPA-3, HPA-4, HPA-5 and/or HPA-15, in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 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
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
10888234500728PakAuto®IMMUCOR GTI DIAGNOSTICS, INC.MYP2017-01-06
10888234500681Concentrated Wash (10X)IMMUCOR GTI DIAGNOSTICS, INC.MYP2016-11-03
10888234500698Stopping SolutionIMMUCOR GTI DIAGNOSTICS, INC.MYP2016-11-03
10888234500704Specimen DiluentIMMUCOR GTI DIAGNOSTICS, INC.MYP2016-11-03
10888234500711Substrate BufferIMMUCOR GTI DIAGNOSTICS, INC.MYP2016-11-03
10888234500216Pak12®IMMUCOR GTI DIAGNOSTICS, INC.MYP2016-07-08
10888234500223Pak12®GIMMUCOR GTI DIAGNOSTICS, INC.MYP2016-07-08
10888234500230Pak2-LEIMMUCOR GTI DIAGNOSTICS, INC.MYP2016-07-08
10888234500247PakAuto®IMMUCOR GTI DIAGNOSTICS, INC.MYP2016-07-08
10888234500254PakPlus®IMMUCOR GTI DIAGNOSTICS, INC.MYP2016-07-08
10888234500261ThromboType®1IMMUCOR GTI DIAGNOSTICS, INC.MYP2016-07-08
10888234500285ThromboType®IMMUCOR GTI DIAGNOSTICS, INC.MYP2016-07-08
10888234500360Stopping SolutionIMMUCOR GTI DIAGNOSTICS, INC.MYP2016-07-08
10888234500377Substrate BufferIMMUCOR GTI DIAGNOSTICS, INC.MYP2016-07-08
10888234500445Specimen DiluentIMMUCOR GTI DIAGNOSTICS, INC.MYP2016-07-08
10888234500452Anti-Human IgG ConjugateIMMUCOR GTI DIAGNOSTICS, INC.MYP2016-07-08
10888234500469Anti-Human IgG ConjugateIMMUCOR GTI DIAGNOSTICS, INC.MYP2016-07-08
10888234500476Buffering SolutionIMMUCOR GTI DIAGNOSTICS, INC.MYP2016-07-08
10888234500490Eluting SolutionIMMUCOR GTI DIAGNOSTICS, INC.MYP2016-07-08
10888234500506Negative Serum ControlIMMUCOR GTI DIAGNOSTICS, INC.MYP2016-07-08
10888234500513Negative Serum ControlIMMUCOR GTI DIAGNOSTICS, INC.MYP2016-07-08
10888234500520Negative Serum ControlIMMUCOR GTI DIAGNOSTICS, INC.MYP2016-07-08
10888234500537Negative Serum ControlIMMUCOR GTI DIAGNOSTICS, INC.MYP2016-07-07
10888234500544Negative Serum ControlIMMUCOR GTI DIAGNOSTICS, INC.MYP2016-07-07
10888234500551Normal Platelet Control (Negative Eluate Control)IMMUCOR GTI DIAGNOSTICS, INC.MYP2016-07-07
10888234500568Positive Platelet Control (Positive Eluate Control)IMMUCOR GTI DIAGNOSTICS, INC.MYP2016-07-07
10888234500575Anti-Human IgG/A/M ConjugateIMMUCOR GTI DIAGNOSTICS, INC.MYP2016-07-07
10888234500582Anti-Human IgG/A/M ConjugateIMMUCOR GTI DIAGNOSTICS, INC.MYP2016-07-07
10888234500599Cell Resuspension and Preservative SolutionIMMUCOR GTI DIAGNOSTICS, INC.MYP2016-07-07
10888234500605Positive Serum ControlIMMUCOR GTI DIAGNOSTICS, INC.MYP2016-07-07