FDA.reportPublic FDA data

STA® - Cephascreen® 4

Primary DI
13607450003083
Brand
STA® - Cephascreen® 4
Company
DIAGNOSTICA STAGO
Model
00308
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
GFOACTIVATED PARTIAL THROMBOPLASTIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFOActivated Partial ThromboplastinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053111000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053111000STA-CEPHASCREEN KITDiagnostica Stago, Inc.2006-05-04GFO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
13607450003083PrimaryGS10
03607450003086Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1360745000308313607450003083
03607450003086036074500030863607450003086

GMDN Terms#

Term, Definition table
TermDefinition
Activated partial thromboplastin time (APTT) IVD, kit, clottingA collection of reagents and other associated materials intended to be used for the quantitative measurement of the activated partial thromboplastin time (APTT) of 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
12
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
00630414640310Dade Actin Activated Cephaloplastin ReagentSiemens Healthcare Diagnostics Products GmbHGFO2024-03-25
00630414640334Dade Actin Activated Cephaloplastin ReagentSiemens Healthcare Diagnostics Products GmbHGFO2024-03-25
00630414640709Pathromtin SLSiemens Healthcare Diagnostics Products GmbHGFO2024-03-25
00630414640716Pathromtin SLSiemens Healthcare Diagnostics Products GmbHGFO2024-03-25
00842768019579Dade Actin Activated Cephaloplastin ReagentSiemens Healthcare Diagnostics Products GmbHGFO2024-03-25
00842768019074Pathromtin SLSiemens Healthcare Diagnostics Products GmbHGFO2024-03-25
00850053916199IDG/SanzayIDG/SANZAY CorporationGFO2024-01-12
00843876000596CRYOcheck Hex LAPrecision Biologic IncGFO2023-05-02
00843876000510CRYOcheck Hex LA Precision Biologic IncGFO2020-11-05
00843876000527CRYOcheck Hex LAPrecision Biologic IncGFO2020-11-05
00817869020014Slide Platelet Aggregation Test ReagentANALYTICAL CONTROL SYSTEMS INCGFO2019-01-31
00842768003837Dade® Actin® Activated Cephaloplastin ReagentSiemens Healthcare Diagnostics Products GmbHGFO2016-09-24
00842768003851Dade® Actin® Activated Cephaloplastin ReagentSiemens Healthcare Diagnostics Products GmbHGFO2016-09-24
00842768007521Pathromtin® SLSiemens Healthcare Diagnostics Products GmbHGFO2016-09-24
00842768007538Pathromtin® SLSiemens Healthcare Diagnostics Products GmbHGFO2016-09-24
08426950087649HemosIL SynthAFaxINSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
08426950433491HemosIL Silica Clotting TimeINSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
08426950023487HemosIL Calcium Chloride 0.025M (for APTT-SP kit)INSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
08426950078920HemosIL SynthASilINSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
08426950078937HemosIL APTT-SPINSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
08426950915676GEM TEST APTT CITRATEINSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
08426950087632HemosIL Calcium Chloride 0.020M (for SynthASil SynthAFax)INSTRUMENTATION LABORATORY COMPANYGFO2016-09-23
00627944000097QuikCoag Calcium Chloride 0.02MBiomedica Diagnostics IncGFO2016-09-22
00627944000103QuikCoag Calcium Choride 0.02MBiomedica Diagnostics IncGFO2016-09-22
10711234103029Hemochron Whole Blood Microcoagulation SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.GFO2016-09-22
00627944000042QuikCoag APTT-EABiomedica Diagnostics IncGFO2016-09-22
00627944000059QuikCoag APTT-EABiomedica Diagnostics IncGFO2016-09-22
10627944000094QuikCoag Calcium Chloride 0.02MBiomedica Diagnostics IncGFO2016-09-22
10627944000100QuikCoag Calcium Choride 0.02MBiomedica Diagnostics IncGFO2016-09-22
00845275000511Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGFO2016-09-16