FDA.reportPublic FDA data

T-tek

Primary DI
10859394006054
Brand
T-tek
Company
R 2 DIAGNOSTICS, INC.
Model
50-201
Catalog number
50-201
Device description
Thrombin Time 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
GJATest, Thrombin Time

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GJATest, Thrombin TimeHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050817000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050817000T-TEKR2 Diagnostics, Inc.2005-12-12GJA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859394006054PrimaryGS10
00859394006057Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085939400605410859394006054
00859394006057008593940060578593940060570859394006057

GMDN Terms#

Term, Definition table
TermDefinition
Thrombin time (TT) IVD, kit, clottingA collection of reagents and other associated materials intended to be used for the quantitative measurement of the thrombin time (TT) of 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
10859394006108LupoTek Detectin VL85-20285-2022016-11-15
10859394006115LupoTek Correctin VL86-20186-2012016-11-15
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
00630414639635Test Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHGJA2024-03-25
00842768012716Test Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHGJA2016-09-24
00842768013102BC Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHGJA2016-09-24
08426950058366HemosIL Thrombin TimeINSTRUMENTATION LABORATORY COMPANYGJA2016-09-23
13607450006114STA® - Thrombin 2DIAGNOSTICA STAGOGJA2016-09-15
13607450006695STA® - Thrombin 10DIAGNOSTICA STAGOGJA2016-09-15
M52553770Thrombin Clotting Time ReagentHELENA LABORATORIES CORPORATIONGJA2016-09-07