FDA.reportPublic FDA data

NoFact IX

Primary DI
10859394006160
Brand
NoFact IX
Company
R 2 DIAGNOSTICS, INC.
Model
69-201
Catalog number
69-201
Device description
Factor IX immunodepleted 10 x 1 ml
Published
2016-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GJTPlasma, Coagulation Factor Deficient

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102908000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102908000NOFACT IXR2 Diagnostics, Inc.2011-12-19GJT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859394006160PrimaryGS10
00859394006163Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085939400616010859394006160
00859394006163008593940061638593940061630859394006163

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation factor IX IVD, kit, clottingA collection of reagents and other associated materials intended to be used for the quantitative detection of coagulation factor IX in a clinical specimen, using a clotting method. Factor IX deficiency may result in a hereditary bleeding disorder known as haemophilia B or Christmas disease.

Regulatory Flags#

DUNS number
956610125
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10859394006061PlasmaCon N30-20130-2012016-11-15
10859394006078PlasmaCon L131-20131-2012016-11-15
10859394006085PlasmaCon L232-20132-2012016-11-15
10859394006122PlasmaCon LA150-200150-2002016-11-15
10859394006139PlasmaCon LA150-201150-2012016-11-15
10859394006016Phospholin ES w/ Calcium Chloride21-41021-4102016-11-15
10859394006023Phosphoplastin RL11-30511-3052016-11-15
10859394006030Phosphoplastin RL11-31011-3102016-11-15
10859394006054T-tek50-20150-2012016-11-15
10859394006108LupoTek Detectin VL85-20285-2022016-11-15
10859394006115LupoTek Correctin VL86-20186-2012016-11-15
10859394006146LupoTek KCT87-30587-3052016-11-15
10859394006153NoFact VIII68-20168-2012016-11-15
10859394006191FIB Calibrator71-20171-2012016-11-15
10859394006238Phospholin ES w/Calcium21-40521-4052016-11-15
00859394006040Fibrotek70-41070-4102016-11-15
00859394006095ThromboTek PSe90-48090-4802016-11-15
10859394006177PlasmaRef ARN33-20133-2012016-11-15
10859394006184PlasmaRef ARL-235-20135-2012016-11-15

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
00815696021082George 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
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