FDA.reportPublic FDA data

TriniCLOT Lupus Screen

Primary DI
15391521420470
Brand
TriniCLOT Lupus Screen
Company
TCOAG IRELAND LIMITED
Model
T1604
Published
2019-06-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GIRReagent, Russel Viper Venom

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIRReagent, Russel Viper VenomHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000527000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000527000ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094Sigma Diagnostics, Inc.2000-04-07GIR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15391521420470PrimaryGS10
05391521420473Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1539152142047015391521420470
05391521420473053915214204735391521420473

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 Temperature00

Regulatory Flags#

DUNS number
985039126
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15391521420487TriniCLOT Lupus ConfirmT16052019-06-28
05391521420572TriniLIA™ D-DimerT31012016-09-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414639451LA 2 Confirmation ReagentSiemens Healthcare Diagnostics Products GmbHGIR2024-03-29
00630414639765LA 1 Screening ReagentSiemens Healthcare Diagnostics Products GmbHGIR2024-03-29
00842768019661LA 2 Confirmation ReagentSiemens Healthcare Diagnostics Products GmbHGIR2024-03-29
00842768019654LA 1 Screening ReagentSiemens Healthcare Diagnostics Products GmbHGIR2024-03-29
00842768007477LA 1 Screening ReagentSiemens Healthcare Diagnostics Products GmbHGIR2020-09-24
00842768007491LA 2 Confirmation ReagentSiemens Healthcare Diagnostics Products GmbHGIR2020-09-24
15391521420487TriniCLOT Lupus ConfirmTCOAG IRELAND LIMITEDGIR2019-06-28
10859394006108LupoTek Detectin VLR 2 DIAGNOSTICS, INC.GIR2016-11-15
10859394006115LupoTek Correctin VLR 2 DIAGNOSTICS, INC.GIR2016-11-15
10859394006122PlasmaCon LAR 2 DIAGNOSTICS, INC.GIR2016-11-15
10859394006139PlasmaCon LAR 2 DIAGNOSTICS, INC.GIR2016-11-15
08426950513704HemosIL dRVVT ScreenINSTRUMENTATION LABORATORY COMPANYGIR2016-09-23
08426950513711HemosIL dRVVT ConfirmINSTRUMENTATION LABORATORY COMPANYGIR2016-09-23
00843876000442CRYOcheck™ LA Check™Precision Biologic IncGIR2016-09-23
00843876000459CRYOcheck™ LA Check™Precision Biologic IncGIR2016-09-23
00843876000466CRYOcheck™ LA Check™Precision Biologic IncGIR2016-09-23
00843876000473CRYOcheck™ LA Check™Precision Biologic IncGIR2016-09-23
00843876000480CRYOcheck™ LA Sure™Precision Biologic IncGIR2016-09-23
00850201006017DVVtest 10Biomedica ADI Inc.GIR2016-09-20
00850201006024DVVconfirm 5Biomedica ADI Inc.GIR2016-09-20
00850201006062DVVtest 25Biomedica ADI Inc.GIR2016-09-20
00850201006123DVVconfirm 10Biomedica ADI Inc.GIR2016-09-20
13607450003335STA® - Staclot® dRVV Screen 5DIAGNOSTICA STAGOGIR2016-09-15
13607450003342STA® - Staclot® dRVV ConfirmDIAGNOSTICA STAGOGIR2016-09-15
13607450003397STA® - Staclot® dRVV Screen 2DIAGNOSTICA STAGOGIR2016-09-15