FDA.reportPublic FDA data

Gamma EGA Kit

Primary DI
10888234000877
Brand
Gamma EGA Kit
Company
IMMUCOR, INC.
Model
0007865
Catalog number
0007865
Device description
Gamma EGA Kit is intended for use in dissociation of IgG from red blood cells so that the treated red blood cells can be further antigen typed or used for serological testing.
Published
2016-04-14
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
KSGMedia, Potentiating For In Vitro Diagnostic Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSGMedia, Potentiating For In Vitro Diagnostic UseHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK9600900

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK9600900

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888234000877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088823400087710888234000877

GMDN Terms#

Term, Definition table
TermDefinition
Red cell antibody eluting IVD, kitA collection of reagents and other associated materials intended to be used for the elution of antibodies bound to antigens present on the surface of red blood cells in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 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
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888234002291Capture LISS006690800669082022-09-03
10888234001027H.P.C. (Human Platelet Concentrate)005732000573202016-04-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060242477959ALBA Elution KitALBA BIOSCIENCE LIMITEDKSG2023-10-13
07611969964505IH-Titration RackBio-Rad Medical Diagnostics GmbHKSG2022-03-09
07611969952205IH-Titration SolutionBio-Rad Medical Diagnostics GmbHKSG2022-03-03
00858400005107PEGAmerican National Red CrossKSG2018-09-17
00858400005121LISSAmerican National Red CrossKSG2018-09-17
10858400005104PEGAMERICAN NATIONAL RED CROSSKSG2018-09-17
10858400005128LISSAMERICAN NATIONAL RED CROSSKSG2018-09-17
23661562105445LISSDIAGASTKSG2018-05-01
07611969952182IH-LISS SolutionBio-Rad Medical Diagnostics GmbHKSG2018-04-05
07611969069934IH-LISS RackBio-Rad Medical Diagnostics GmbHKSG2017-01-20
00858352006023ELUclear HEMO BIOSCIENCE INCKSG2016-09-27
10758750006038MTSMICRO TYPING SYSTEMS, INCKSG2016-08-24
10758750006045MTSMICRO TYPING SYSTEMS, INCKSG2016-08-24
10758750007820ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.KSG2016-08-24
10758750007837ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.KSG2016-08-24
10888234000167ImmuAddIMMUCOR, INC.KSG2016-04-15
10888234000235Bovine Albumin Solution 22%IMMUCOR, INC.KSG2016-04-15
10888234001775Gamma LO-IONIMMUCOR, INC.KSG2016-04-15
10888234001782Gamma PeGIMMUCOR, INC.KSG2016-04-15
10888234001799Gamma PeGIMMUCOR, INC.KSG2016-04-15
10888234001805Gamma N-HANCEIMMUCOR, INC.KSG2016-04-15
10888234001812Gamma N-HANCEIMMUCOR, INC.KSG2016-04-15
10888234000860Gamma ELU-KIT IIIMMUCOR, INC.KSG2016-04-14
05060242471520Bovine Serum Albumin 22%ALBA BIOSCIENCE LIMITEDKSG2014-11-14
05060242471537ALBAhance PEGALBA BIOSCIENCE LIMITEDKSG2014-11-14