FDA.reportPublic FDA data

H.P.C. (Human Platelet Concentrate)

Primary DI
10888234001027
Brand
H.P.C. (Human Platelet Concentrate)
Company
IMMUCOR, INC.
Model
0057320
Catalog number
0057320
Device description
H.P.C. (Human Platelet Concentrate) is used to reduce or remove HLA (Bg) activity from serum as an aid in antibody detection and identification. H.P.C. is a dry preparation of a washed pool of platelets from individual human platelet donors. This product is a dry preparation which must be rehydrated before use. This product configuration has ten (10) vials.
Published
2016-04-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
BK8500080

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK8500080

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888234001027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088823400102710888234001027

GMDN Terms#

Term, Definition table
TermDefinition
Multiple human platelet antigen (HPA) typing IVD, kit, agglutinationA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple 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, using an agglutination method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius10 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-466-8267tech_support@immucor.com

Regulatory Flags#

DUNS number
061446282
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888234002291Capture LISS006690800669082022-09-03
10888234002475ImmuLINK00303112024-12-05
10888234000495Red Blood Cell (RBC) Storage Solution000503600050362016-04-15
10888234001065Specimen Diluent006605200660522016-04-18
10888234001072Specimen Diluent006605300660532016-04-18
10888234001041Galileo Neo006459900645992016-04-18
10888234001584Galileo Echo008700000870002016-04-18
10888234001591CMT Plates008900000890002016-04-18
10888234002321NEO Iris006459700645972018-12-10
10888234002338Echo Lumena008699800869982018-06-01
10888234001546Capture-R Positive Control Serum (Weak), Capture-R Negative Control Serum006690200669022022-09-03
10888234001553Capture-R Select006690300669032022-09-03
10888234001560Capture-P006690400669042022-09-03
10888234001577Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum006690500669052022-09-03
10888234002307Capture-R Ready Indicator Red Cells006690700669072022-09-03
10888234002314Capture-P Indicator Red Cells006690600669062022-09-03
10888234001522Referencells006690000669002022-08-03
10888234001539Capture-R Ready-Screen 3006690100669012022-08-01
10888234002239Gamma-Clone Anti-Fya (Monoclonal) Blood Grouping Reagent10 mL size vial / 5mL fill volume00664302022-04-22
10888234002420Anti-s (Monoclonal) Gamma-clone006642900664292022-04-22

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
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