FDA.reportPublic FDA data

STA® - Liatest® VWF:Ag

Primary DI
03607450005189
Brand
STA® - Liatest® VWF:Ag
Company
DIAGNOSTICA STAGO
Model
00518
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K962675000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962675000STA - LIATEST VWF TEST KITAmerican Bioproducts Co.1996-10-25GJT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03607450005189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03607450005189036074500051893607450005189

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation factor VIII-associated antigen IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of coagulation factor VIII-associated antigen, also known as von Willebrand antigen, in a clinical specimen using a nephelometry/turbidimetry method. It is typically used in the diagnosis of congenital or acquired von Willebrand's disease.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
262277122
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03607450006766STA® - Coag Control N + ABN006762016-09-15
03607450006773STA® - Coag Control (N + ABN) PLUS006772016-09-15
03607450006780STA® - System Control N + P006782016-09-15
03607450005264STA® - Liatest® Control N + P005262016-09-15
13607450006756STA® - Unicalibrator006752016-09-15
13607450011392Pool Norm011392016-09-15
03607450005400FDP Plasma005402016-09-15
13607450005414FDP Plasma (Latex)005412016-09-15
13607450005513FDP Plasma (Buffer)005512016-09-15
13607450006749STA® - Fibrinogen 5006742016-09-15
03607450589894STA Compact Max® (with cap piercing option)589892016-09-15
03607450589900STA Compact Max®589902016-09-15
03607450590265STA R Max®590262018-10-30
03607450590272STA R Max® (with cap piercing option)590272018-10-30
13607450009757STA® - Desorb U009752020-09-24
03607450009736STA® - Cleaner Solution009732020-09-29
13607450003601STA® - Owren-Koller003602018-09-24
03607450000030STA Coag Expert®V8871112022-12-09
03607450000047Coag.One server licenseV8867652022-12-09
03607450867657Coag.One server licenseV7867652022-12-09

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
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