FDA.reportPublic FDA data

TriniCHECK™ D-Dimer 1

Primary DI
15391521420777
Brand
TriniCHECK™ D-Dimer 1
Company
TCOAG IRELAND LIMITED
Model
T4303
Published
2016-09-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GIZPlasma, Control, Normal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIZPlasma, Control, NormalHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003328000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003328000ACCUCLOT CONTROL I, MODEL A4089Sigma Diagnostics, Inc.2001-03-01GIZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15391521420777PrimaryGS10
05391521420770Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1539152142077715391521420777
05391521420770053915214207705391521420770

GMDN Terms#

Term, Definition table
TermDefinition
D-dimer IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of D-dimer protein in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985039126
Device count
4
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
15391521420630TriniCHECK Level 1T41112019-06-28
15391521420647TriniCHECK Level 2T41122019-06-28
15391521420654TriniCHECK Level 3T41132019-06-28
15391521420708TriniCAL™ Reference PlasmaT51022016-09-12
15391521421101TriniCHECK™ Abnormal controlT41042016-09-12
05391521420718TriniVerical™ T51032016-09-12
05391521420534TriniCHROM™ Antithrombin IIaT26022016-09-12
15391521420234TriniCLOT™ PT HTF 20 mLT11012016-09-12
15391521420241TriniCLOT™ PT HTF 6 mLT11022016-09-12
15391521420340TriniCLOT™ Automated aPTT 3 mLT12062016-09-12
15391521420661TriniCHECK™ Lupus Positive ControlT42032016-09-12
15391521421125Destiny System FluidDSF2016-09-12
05391521420282TriniCLOT™ PT Excel 6 mLT11062016-09-12
05391521420305TriniCLOT™ aPTT S 3 mLT12022016-09-12
05391521420541TriniCHROM™ Antithrombin XaT26032016-09-12
05391521421029Destiny PlusH01000P2016-09-12
05391521421081Destiny MAX AnalyzerM010002016-09-12
15391521421309DT WashDTW2019-06-28
15391521421729DT FluidDTF2019-06-28
15391521420067Adenosine Diphosphate (ADP)507042016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10859394006061PlasmaCon NR 2 DIAGNOSTICS, INC.GIZ2016-11-15
10859394006078PlasmaCon L1R 2 DIAGNOSTICS, INC.GIZ2016-11-15
10859394006085PlasmaCon L2R 2 DIAGNOSTICS, INC.GIZ2016-11-15
00842768006821Berichrom® Heparin UF Control 1Siemens Healthcare Diagnostics Products GmbHGIZ2016-09-24
00842768006876Berichrom® Heparin LMW Control 1Siemens Healthcare Diagnostics Products GmbHGIZ2016-09-24
00843876000053CRYOcheck™ Reference Control NormalPrecision Biologic IncGIZ2016-09-23
00843876000060CRYOcheck™ Reference Control NormalPrecision Biologic IncGIZ2016-09-23
00850201006147LAtrol NORMAL CONTROL PLASMABiomedica ADI Inc.GIZ2016-09-20
00845275000559Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGIZ2016-09-16
13607450006756STA® - UnicalibratorDIAGNOSTICA STAGOGIZ2016-09-15
M52553010Coagulation S.A.C.-1 (Specialty Assay Control)HELENA LABORATORIES CORPORATIONGIZ2016-09-07
00855360006243REAADS Coagulation Control 1CORGENIX MEDICAL CORPORATIONGIZ2016-07-14