FDA.reportPublic FDA data

GammaZyme-F

Primary DI
10888234000709
Brand
GammaZyme-F
Company
IMMUCOR, INC.
Model
0007056
Catalog number
0007056
Device description
GammaZyme-F is used in two-stage (pretreatment of red blood cells) enzyme test systems for blood group antibody detection. GammaZyme-F is a stabilized solution of ficin, and this product is in a single vial configuration.
Published
2016-04-15
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
KSKSolution, Stabilized Enzyme

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSKSolution, Stabilized EnzymeHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK8800160

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK8800160

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888234000709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088823400070910888234000709

GMDN Terms#

Term, Definition table
TermDefinition
Ficin immunohaematology reagent IVDA substance or reactant that is a ficin enzyme solution intended to be used in immunohaematological testing of a clinical specimen to enhance or potentiate red cell agglutination reactions by enzymatically digesting red cell membrane proteins and removing sialic acid residues.

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
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
23661562105452PapainDIAGASTKSK2018-05-01
07611969952199IH-PapainBio-Rad Medical Diagnostics GmbHKSK2018-04-05
10758750030330ORTHOTM Sera Papain ALBA BIOSCIENCE LIMITEDKSK2017-08-30
05060242471223ALBAzyme™ Papain Solution KitALBA BIOSCIENCE LIMITEDKSK2017-03-29
10888234000891Gamma-QuinIMMUCOR, INC.KSK2016-04-19
10888234001010W.A.R.M.IMMUCOR, INC.KSK2016-04-18
10888234000716GammaZyme-BIMMUCOR, INC.KSK2016-04-15
10888234000990Freeze Dried PapainIMMUCOR, INC.KSK2016-04-15
23661562173307Beckman Coulter® PK® Systems BromelinDIAGASTKSK2015-09-18
05060242471544ALBAhance LISS Additive ReagentALBA BIOSCIENCE LIMITEDKSK2014-11-14