FDA.reportPublic FDA data

STA® - Deficient II

Primary DI
13607450007456
Brand
STA® - Deficient II
Company
DIAGNOSTICA STAGO
Model
00745
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
GJSTEST, TIME, PROTHROMBIN
GJTPLASMA, COAGULATION FACTOR DEFICIENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GJSTest, Time, ProthrombinHematology2
GJTPlasma, Coagulation Factor DeficientHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K934606000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K934606000STAGO FACTOR II-DEFICIENT PLASMAAmerican Bioproducts Co.1994-03-01GJT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
13607450007456PrimaryGS10
03607450007459Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1360745000745613607450007456
03607450007459036074500074593607450007459

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation factor II (prothrombin) IVD, kit, clottingA collection of reagents and other associated materials intended to be used for the quantitative measurement of coagulation factor II (prothrombin) in a clinical specimen, using a clotting method.

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
6
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
08436540291141microINR® Expert KitILINE MICROSYSTEMS SLGJS2026-04-22
09360136000079 Xprecia Prime™ Coagulation AnalyzerUNIVERSAL BIOSENSORS PTY LTDGJS2024-08-27
09360136000086 Xprecia Prime™ Coagulation AnalyzerUNIVERSAL BIOSENSORS PTY LTDGJS2024-08-27
09360136000093Xprecia Prime™ PT/INR Test StripsUNIVERSAL BIOSENSORS PTY LTDGJS2024-08-27
08436540291134microINR ® Link KitILINE MICROSYSTEMS SLGJS2024-08-02
08436540290915microINR ® Link KitILINE MICROSYSTEMS SLGJS2024-08-02
00850053916205IDG/SanzayIDG/SANZAY CorporationGJS2024-07-03
08436540290908microINR ® Link KitILINE MICROSYSTEMS SLGJS2024-04-01
00630414639598Coagulation Factor X Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00630414639604Coagulation Factor XI Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00630414639871Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00630414639888Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00630414639963Thromborel SSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00630414640006Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
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
00842768019593Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00842768019609Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00842768018749Thromborel SSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00842768019586Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
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