FDA.reportPublic FDA data

George King FVII Deficient Plasma

Primary DI
00815696021082
Brand
George King FVII Deficient Plasma
Company
GEORGE KING BIO-MEDICAL, INC
Model
0070-250.0 mL
Device description
George King Factor FVII Deficient Plasma is fresh frozen citrated human plasma derived from congenital FVII Deficient donors.
Published
2017-06-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GJTPlasma, Coagulation Factor Deficient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GJTPlasma, Coagulation Factor DeficientHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815696021082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815696021082008156960210828156960210820815696021082

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation factor VII 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 for the quantitative measurement of coagulation factor VII in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00-70˚C or below

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-255-5108plasma@kingbiomed.com

Regulatory Flags#

DUNS number
066761271
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815696021341George King SysCOR-40 Control Kit0065-402023-03-15
00815696021297George King Pooled Normal Plasma0010-60.02022-03-03
00815696021303George King Single Donor Normal Plasma0001-60.02022-03-03
00815696021259George King Pooled Normal Plasma0010-10.02021-01-08
00815696021228George King Single Donor Normal Plasma0001-50.02020-06-26
00815696021235George King SDN Control Kit0075-102020-06-26
00815696021198George King Pooled Normal Plasma0010-500.02019-10-04
00815696021204George King SDN Control Kit0075-202019-11-18
00815696020108George King Pooled Normal Plasma0010-1.02016-07-15
00815696020115George King Pooled Normal Plasma0010-0.52016-08-21
00815696020122George King Pooled Normal Plasma0010-1.52016-08-21
00815696020139George King Pooled Normal Plasma0010-5.02016-08-21
00815696020153George King Single Donor Normal Plasma0001-1.02016-08-21
00815696020160George King Single Donor Normal Plasma0001-bulk2016-08-21
00815696020245George King Pooled Normal Plasma0010-50.02016-08-21
00815696020276George King Pooled Normal Plasma0010-100.02016-08-21
00815696020283George King Pooled Normal Plasma0010-200.02016-08-21
00815696020290George King Pooled Normal Plasma0010-250.02016-08-21
00815696020368George King FACT0020-0.52016-08-17
00815696020375George King FACT0020-1.02016-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414639598Coagulation Factor X Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00630414639604Coagulation Factor XI Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00630414640587Coagulation Factor IX Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00630414640679Coagulation Factor XII Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00630414640686Coagulation Factor II Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00630414640761Coagulation Factor VIII Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00630414640792Coagulation Factor VII Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00842768018817Coagulation Factor X Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00842768018879Coagulation Factor XI Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00842768018824Coagulation Factor IX Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00842768018862Coagulation Factor XII Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00842768018855Coagulation Factor II Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00842768018831Coagulation Factor VIII Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00842768018848Coagulation Factor VII Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00630414640754Coagulation Factor V Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-02-19
00842768018886Coagulation Factor V Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-02-19
00843876000572CRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic IncGJT2023-09-25
00843876000589CRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic IncGJT2023-09-25
00843876010557CRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic IncGJT2023-09-25
00843876010564CRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic IncGJT2023-09-25
00815696021310George King Factor VIII Deficient PlasmaGEORGE KING BIO-MEDICAL, INCGJT2022-03-03
00815696021211George King Factor V Deficient PlasmaGEORGE KING BIO-MEDICAL, INCGJT2020-02-27
00815696021075George King FVII Deficient PlasmaGEORGE KING BIO-MEDICAL, INCGJT2017-06-26
00815696021037George King Congential Factor Deficiency Convenience KitGEORGE KING BIO-MEDICAL, INCGJT2017-03-20
10859394006153NoFact VIIIR 2 DIAGNOSTICS, INC.GJT2016-11-15
10859394006160NoFact IXR 2 DIAGNOSTICS, INC.GJT2016-11-15
00842768009525Coagulation Factor V Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2016-09-24
00842768009976Coagulation Factor XI Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2016-09-24
00842768009990Coagulation Factor XII Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2016-09-24
00842768010156Coagulation Factor II Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2016-09-24