FDA.reportPublic FDA data

LupoTek Correctin VL

Primary DI
10859394006115
Brand
LupoTek Correctin VL
Company
R 2 DIAGNOSTICS, INC.
Model
86-201
Catalog number
86-201
Device description
Venom Confirmatory test for LA 10 x 1 ml
Published
2016-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GGCControl, Plasma, Abnormal
GIRReagent, Russel Viper Venom

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGCControl, Plasma, AbnormalHematology2
GIRReagent, Russel Viper VenomHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083878000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083878000LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LAR2 Diagnostics, Inc.2010-06-25GIR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859394006115PrimaryGS10
00859394006118Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085939400611510859394006115
00859394006118008593940061188593940061180859394006118

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.

Regulatory Flags#

DUNS number
956610125
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10859394006061PlasmaCon N30-20130-2012016-11-15
10859394006078PlasmaCon L131-20131-2012016-11-15
10859394006085PlasmaCon L232-20132-2012016-11-15
10859394006122PlasmaCon LA150-200150-2002016-11-15
10859394006139PlasmaCon LA150-201150-2012016-11-15
10859394006016Phospholin ES w/ Calcium Chloride21-41021-4102016-11-15
10859394006023Phosphoplastin RL11-30511-3052016-11-15
10859394006030Phosphoplastin RL11-31011-3102016-11-15
10859394006054T-tek50-20150-2012016-11-15
10859394006108LupoTek Detectin VL85-20285-2022016-11-15
10859394006146LupoTek KCT87-30587-3052016-11-15
10859394006153NoFact VIII68-20168-2012016-11-15
10859394006160NoFact IX69-20169-2012016-11-15
10859394006191FIB Calibrator71-20171-2012016-11-15
10859394006238Phospholin ES w/Calcium21-40521-4052016-11-15
00859394006040Fibrotek70-41070-4102016-11-15
00859394006095ThromboTek PSe90-48090-4802016-11-15
10859394006177PlasmaRef ARN33-20133-2012016-11-15
10859394006184PlasmaRef ARL-235-20135-2012016-11-15

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
00630414639451LA 2 Confirmation ReagentSiemens Healthcare Diagnostics Products GmbHGIR2024-03-29
00630414639765LA 1 Screening ReagentSiemens Healthcare Diagnostics Products GmbHGIR2024-03-29
00630414640013LA Control LowSiemens Healthcare Diagnostics Products GmbHGGC2024-03-29
00630414640099LA Control HighSiemens Healthcare Diagnostics Products GmbHGGC2024-03-29
00842768019661LA 2 Confirmation ReagentSiemens Healthcare Diagnostics Products GmbHGIR2024-03-29
00842768019654LA 1 Screening ReagentSiemens Healthcare Diagnostics Products GmbHGIR2024-03-29
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
00842768007477LA 1 Screening ReagentSiemens Healthcare Diagnostics Products GmbHGIR2020-09-24
00842768007491LA 2 Confirmation ReagentSiemens Healthcare Diagnostics Products GmbHGIR2020-09-24
00815696021143George King Positive Lupus AnticoagulantGEORGE KING BIO-MEDICAL, INCGGC2020-03-27
00815696021150George King Factor XIII Deficient PlasmaGEORGE KING BIO-MEDICAL, INCGGC2020-03-27
15391521420470TriniCLOT Lupus ScreenTCOAG IRELAND LIMITEDGIR2019-06-28
15391521420487TriniCLOT Lupus ConfirmTCOAG IRELAND LIMITEDGIR2019-06-28
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.GIR2016-11-15