FDA.reportPublic FDA data

George King A-FACT

Primary DI
00815696020382
Brand
George King A-FACT
Company
GEORGE KING BIO-MEDICAL, INC
Model
0030-0.5
Device description
George King A-FACT is a low abnormal fresh frozen citrated control that is used to verify the performance of an assay intended to be used for the quantitative determination of multiple coagulation factors, intermediates and/or activated components.
Published
2016-08-17
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
GGNPlasma, Coagulation Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGNPlasma, Coagulation ControlHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K945855000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945855000A-FACT, ABNORMAL FACTOR ASSAY CONTROLGeorge King Bio-Medical, Inc.1995-10-24GGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815696020382PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815696020382008156960203828156960203820815696020382

GMDN Terms#

Term, Definition table
TermDefinition
Multiple coagulation factor IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components 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
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
00815696021327George King Heparin Control Plasma GEORGE KING BIO-MEDICAL, INCGGN2025-07-11
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