FDA.reportPublic FDA data

TriniCAL™ Fibrinogen

Primary DI
15391521420722
Brand
TriniCAL™ Fibrinogen
Company
TCOAG IRELAND LIMITED
Model
T5104
Published
2016-09-12
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
KQJSystem, Fibrinogen Determination

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQJSystem, Fibrinogen DeterminationHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971858000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971858000SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)Sigma Diagnostics, Inc.1997-10-09KQJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15391521420722PrimaryGS10
05391521420725Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1539152142072215391521420722
05391521420725053915214207255391521420725

GMDN Terms#

Term, Definition table
TermDefinition
Fibrinogen assay (factor I) IVD, kit, clottingA collection of reagents and other associated materials intended to be used for the quantitative measurement of fibrinogen (factor I) 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
985039126
Device count
10
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
15391521420777TriniCHECK™ D-Dimer 1T43032016-09-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414639734Multifibren USiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00630414639741Multifibren USiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00630414639901Dade CA System BufferSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00630414640150Dade Data-Fi Abnormal Fibrinogen ControlSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00630414640266Dade Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00630414640273Dade Owren's Veronal BufferSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00630414640372Dade Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768018541Multifibren USiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768018503Multifibren USiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768019845Dade CA System BufferSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768019524Dade Data-Fi Abnormal Fibrinogen ControlSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768019517Dade Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768019494Dade Owren's Veronal BufferSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768019500Dade Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00630414640532Kaolin SuspensionSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
G0561009890Calcium ChlorideBio/Data CorporationKQJ2023-08-30
00859394006040FibrotekR 2 DIAGNOSTICS, INC.KQJ2016-11-15
05051700010726Human Fibrinogen BINDARID™ Radial Immunodiffusion KitTHE BINDING SITE GROUP LIMITEDKQJ2016-09-24
00842768003936Dade® Data-Fi® Abnormal Fibrinogen ControlSiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768003943Dade® Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768003950Dade® Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768003981Dade® Owren's Veronal BufferSiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768007170Kaolin SuspensionSiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768017865Multifibren® USiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768017872Multifibren® USiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768039416Dade® CA System BufferSiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
08426950451976HemosIL Low Fibrinogen ControlINSTRUMENTATION LABORATORY COMPANYKQJ2016-09-23
08426950087618HemosIL Fibrinogen-C XLINSTRUMENTATION LABORATORY COMPANYKQJ2016-09-23
08426950478676HemosIL Fibrinogen-CINSTRUMENTATION LABORATORY COMPANYKQJ2016-09-23
13607450006749STA® - Fibrinogen 5DIAGNOSTICA STAGOKQJ2016-09-15