FDA.reportPublic FDA data

TriniCHECK™ Lupus Positive Control

Primary DI
15391521420661
Brand
TriniCHECK™ Lupus Positive Control
Company
TCOAG IRELAND LIMITED
Model
T4203
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
GGCControl, Plasma, Abnormal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGCControl, Plasma, AbnormalHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961370000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961370000LA POSITIVE CONTROL PLASMAMedical Diagnostic Technologies, Inc.1996-05-24GGC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15391521420661PrimaryGS10
05391521420664Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1539152142066115391521420661
05391521420664053915214206645391521420664

GMDN Terms#

Term, Definition table
TermDefinition
Lupus anticoagulant marker IVD, kit, clottingA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple Lupus anticoagulant markers 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
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
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
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
15391521420067Adenosine Diphosphate (ADP)507042016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198815000107Recombinant Factor VIII Substrate, Porcine SequenceTakeda Pharmaceuticals U.S.A., Inc.GGC2025-08-01
00630414640013LA Control LowSiemens Healthcare Diagnostics Products GmbHGGC2024-03-29
00630414640099LA Control HighSiemens Healthcare Diagnostics Products GmbHGGC2024-03-29
00842768019678LA Control LowSiemens Healthcare Diagnostics Products GmbHGGC2024-03-29
00842768019685LA Control HighSiemens Healthcare Diagnostics Products GmbHGGC2024-03-29
00630414640167Dade Ci-Trol Coagulation Control Level 1Siemens Healthcare Diagnostics Products GmbHGGC2024-03-25
00842768019470Dade Ci-Trol Coagulation Control Level 1Siemens Healthcare Diagnostics Products GmbHGGC2024-03-25
00630414639703Control Plasma PSiemens Healthcare Diagnostics Products GmbHGGC2024-02-19
00842768018589Control Plasma PSiemens Healthcare Diagnostics Products GmbHGGC2024-02-19
00815696021341George King SysCOR-40 Control KitGEORGE KING BIO-MEDICAL, INCGGC2023-03-15
00815696021143George King Positive Lupus AnticoagulantGEORGE KING BIO-MEDICAL, INCGGC2020-03-27
00815696021150George King Factor XIII Deficient PlasmaGEORGE KING BIO-MEDICAL, INCGGC2020-03-27
00817869020243Animal Plasma Control Level IIANALYTICAL CONTROL SYSTEMS INCGGC2019-01-31
00815696021112George King Positive Lupus AnticoagulantGEORGE KING BIO-MEDICAL, INCGGC2018-06-22
00815696021051George King AbCOR Convenience KitGEORGE KING BIO-MEDICAL, INCGGC2017-04-17
00815696021068George King AbCOR Convenience KitGEORGE KING BIO-MEDICAL, INCGGC2017-04-17
00630414023502LA Control LowSiemens Healthcare Diagnostics Products GmbHGGC2017-02-15
00630414023519LA Control HighSiemens Healthcare Diagnostics Products GmbHGGC2017-02-15
10859394006061PlasmaCon NR 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006078PlasmaCon L1R 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006085PlasmaCon L2R 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006108LupoTek Detectin VLR 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006115LupoTek Correctin VLR 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006122PlasmaCon LAR 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006139PlasmaCon LAR 2 DIAGNOSTICS, INC.GGC2016-11-15
00842768004056Dade® Ci-Trol® Coagulation Control Level 1Siemens Healthcare Diagnostics Products GmbHGGC2016-09-24
00842768006838Berichrom® Heparin UF Control 2Siemens Healthcare Diagnostics Products GmbHGGC2016-09-24
00842768006852Berichrom® Heparin LMW Control 2Siemens Healthcare Diagnostics Products GmbHGGC2016-09-24
00842768008351LA Control HighSiemens Healthcare Diagnostics Products GmbHGGC2016-09-24
00842768008368LA Control LowSiemens Healthcare Diagnostics Products GmbHGGC2016-09-24