FDA.reportPublic FDA data

Recombinant Factor VIII Substrate, Porcine Sequence

Primary DI
00198815000107
Brand
Recombinant Factor VIII Substrate, Porcine Sequence
Company
Takeda Pharmaceuticals U.S.A., Inc.
Model
6521753
Catalog number
6521753
Published
2025-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GGCControl, Plasma, Abnormal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGCControl, Plasma, AbnormalHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198815000107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198815000107001988150001071988150001070198815000107

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation factor VIII IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of coagulation factor VIII in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit46 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
041877817
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

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Primary DIBrandModelCatalogPublished
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00850025688291HyHub Vial Access Device550022255002222025-09-23
00850025688819myPKFiT for Healthcare ProfessionalsV32025-01-03
00850025688826myPKFiT for Patients Mobile ApplicationV22025-01-03
00850025688871BAXJECT II Hi-Flow34007692024-06-12
00850025688864BAXJECT II650781665078162024-02-29
00850025688888Anti-Drug Antibody Biomarker Specimen Collection Kit500083350008332023-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414640013LA Control LowSiemens Healthcare Diagnostics Products GmbHGGC2024-03-29
00630414640099LA Control HighSiemens Healthcare Diagnostics Products GmbHGGC2024-03-29
00842768019678LA Control LowSiemens Healthcare Diagnostics Products GmbHGGC2024-03-29
00842768019685LA Control HighSiemens Healthcare Diagnostics Products GmbHGGC2024-03-29
00630414640167Dade Ci-Trol Coagulation Control Level 1Siemens Healthcare Diagnostics Products GmbHGGC2024-03-25
00842768019470Dade Ci-Trol Coagulation Control Level 1Siemens Healthcare Diagnostics Products GmbHGGC2024-03-25
00630414639703Control Plasma PSiemens Healthcare Diagnostics Products GmbHGGC2024-02-19
00842768018589Control Plasma PSiemens Healthcare Diagnostics Products GmbHGGC2024-02-19
00815696021341George King SysCOR-40 Control KitGEORGE KING BIO-MEDICAL, INCGGC2023-03-15
00815696021143George King Positive Lupus AnticoagulantGEORGE KING BIO-MEDICAL, INCGGC2020-03-27
00815696021150George King Factor XIII Deficient PlasmaGEORGE KING BIO-MEDICAL, INCGGC2020-03-27
00817869020243Animal Plasma Control Level IIANALYTICAL CONTROL SYSTEMS INCGGC2019-01-31
00815696021112George King Positive Lupus AnticoagulantGEORGE KING BIO-MEDICAL, INCGGC2018-06-22
00815696021051George King AbCOR Convenience KitGEORGE KING BIO-MEDICAL, INCGGC2017-04-17
00815696021068George King AbCOR Convenience KitGEORGE KING BIO-MEDICAL, INCGGC2017-04-17
00630414023502LA Control LowSiemens Healthcare Diagnostics Products GmbHGGC2017-02-15
00630414023519LA Control HighSiemens Healthcare Diagnostics Products GmbHGGC2017-02-15
10859394006061PlasmaCon NR 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006078PlasmaCon L1R 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006085PlasmaCon L2R 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006108LupoTek Detectin VLR 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006115LupoTek Correctin VLR 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006122PlasmaCon LAR 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006139PlasmaCon LAR 2 DIAGNOSTICS, INC.GGC2016-11-15
00842768004056Dade® Ci-Trol® Coagulation Control Level 1Siemens Healthcare Diagnostics Products GmbHGGC2016-09-24
00842768006838Berichrom® Heparin UF Control 2Siemens Healthcare Diagnostics Products GmbHGGC2016-09-24
00842768006852Berichrom® Heparin LMW Control 2Siemens Healthcare Diagnostics Products GmbHGGC2016-09-24
00842768008351LA Control HighSiemens Healthcare Diagnostics Products GmbHGGC2016-09-24
00842768008368LA Control LowSiemens Healthcare Diagnostics Products GmbHGGC2016-09-24
00842768011580Control Plasma PSiemens Healthcare Diagnostics Products GmbHGGC2016-09-24