FDA.reportPublic FDA data

Specimen Diluent

Primary DI
10888234500704
Brand
Specimen Diluent
Company
IMMUCOR GTI DIAGNOSTICS, INC.
Model
404582
Catalog number
404582
Device description
For Use with PakPlus100
Published
2016-11-03
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888234500704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088823450070410888234500704

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 Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-466-8267waukeshatechsupport@immucor.co
855-466-8267waukeshatechsupport@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
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
10888234500407Concentrated Wash (10X)IMMUCOR 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