FDA.reportPublic FDA data

George King Heparin Control Plasma

Primary DI
00815696021327
Brand
George King Heparin Control Plasma
Company
GEORGE KING BIO-MEDICAL, INC
Model
7000-1.0
Device description
George King (GK) Heparin Control Plasma is an assayed citrated plasma intended for the control of Unfractionated Heparin (UFH) activity using ananti-Xa chromogenic assay and coagulation analyzer with appropriate commercial anti-Xa reagents.
Published
2025-07-11
Public version status
New
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
GGNPlasma, Coagulation Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGNPlasma, Coagulation ControlHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815696021327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815696021327008156960213278156960213270815696021327

GMDN Terms#

Term, Definition table
TermDefinition
Heparin anti-Xa IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative monitoring of heparin anticoagulant therapy by determining its ability to inhibit the activity of activated factor X (factor Xa) 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
050700024203855-PLASMA Bivalirudin Control5-Diagnostics LtdGGN2026-04-02
08426951011131HemosIL CL Multi-Ab ControlsINSTRUMENTATION LABORATORY COMPANYGGN2025-10-30
08718734962724CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962731CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962748CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962755CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962762CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962779CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962786CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962793CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962809CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962816CueSee® CoagEurotrol B.V.GGN2025-04-08
09360136000055Xprecia™ Systems PT ControlsUNIVERSAL BIOSENSORS PTY LTDGGN2024-08-27
08430793242998HEMOSIL RIVAROXABAN CONTROLSINSTRUMENTATION LABORATORY COMPANYGGN2024-07-22
00630414639840INNOVANCE Heparin UF Control 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414639857INNOVANCE Heparin LMW Control 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414639949INNOVANCE Heparin UF Control 1Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414639956INNOVANCE Heparin LMW Control 1Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414640280Dade Ci-Trol Coagulation Control Level 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414640426Dade Ci-Trol Coagulation Control Level 3Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414640624ProC Control PlasmaSiemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414229522INNOVANCE Heparin UF Control 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414229546INNOVANCE Heparin LMW Control 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414229515INNOVANCE Heparin UF Control 1Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414229539INNOVANCE Heparin LMW Control 1Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00842768019463Dade Ci-Trol Coagulation Control Level 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00842768019456Dade Ci-Trol Coagulation Control Level 3Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00842768019005ProC Control PlasmaSiemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414640747Control Plasma N Siemens Healthcare Diagnostics Products GmbHGGN2024-02-19
00842768018909Control Plasma N Siemens Healthcare Diagnostics Products GmbHGGN2024-02-19