FDA.reportPublic FDA data

Coagulation Factor IX Deficient Plasma

Primary DI
00630414640587
Brand
Coagulation Factor IX Deficient Plasma
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10873881
Catalog number
10873881
Device description
For the determination of the activity of coagulation factor IX in human plasma by coagulometric methods
Published
2024-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K924396000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K924396000CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMABehring Diagnostics, Inc.1993-05-21GJT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414640587PrimaryGS10
00842768018824Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414640587006304146405876304146405870630414640587
00842768018824008427680188248427680188240842768018824

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation factor IX 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 IX in a clinical specimen.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)242-3233CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
388240673
Device count
8
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842768013317N Latex ADNase B10446658OWTI112020-09-24
00842768006210DImension Vista® Prealbumin Flex® reagent cartridge10445906K70642020-09-24
00842768012167N Cuvette Segments for BN II10446520OVIB312017-11-15
00842768012198Behring Coagulation Cup10446526OVIS312017-10-31
00842768012297N Evaporation Caps for Control Vials (2.5 mL)10446534OVLC212017-10-31
00842768012303N Evaporation Caps for Reagent Vials (5 ml)10446535OVLC312017-10-31
00842768013065Enzygnost® TAT micro10446632OWMG152016-09-24
00842768014246N Reaction Buffer10446455OUMS652016-09-24
00842768017742Washing Solution for Coagulation Analyzers10446684OWZC392016-09-24
00842768024887BFT II Analyzer10458677OVKF0322016-09-24
00630414639703Control Plasma P10873891108738912024-02-19
00630414639772Standard Human Plasma10873907108739072024-03-25
00630414640167Dade Ci-Trol Coagulation Control Level 110873842108738422024-03-25
00630414640259Dade Ci-Trol Heparin Control, Low10873833108738332024-03-25
00630414640280Dade Ci-Trol Coagulation Control Level 210873843108738432024-03-25
00630414640365Dade Ci-Trol Heparin Control, High10873834108738342024-03-25
00630414640426Dade Ci-Trol Coagulation Control Level 310873844108738442024-03-25
00630414640747Control Plasma N 10873874108738742024-02-19
00842768003899Dade® Ci-Trol® Heparin Control, Low10445715B4224-502016-09-24
00842768003905Dade® Ci-Trol® Heparin Control, High10445716B4224-602016-09-24

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
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
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