FDA.reportPublic FDA data

ThromboTek PSe

Primary DI
00859394006095
Brand
ThromboTek PSe
Company
R 2 DIAGNOSTICS, INC.
Model
90-480
Catalog number
90-480
Device description
Protein S Kit 80-160 DET
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
GGPTest, Qualitative And Quantitative Factor Deficiency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGPTest, Qualitative And Quantitative Factor DeficiencyHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082631000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082631000THROMBO TEK PSE, MODEL 90-480R2 Diagnostics, Inc.2008-12-17GGP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859394006095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859394006095008593940060958593940060950859394006095

GMDN Terms#

Term, Definition table
TermDefinition
Protein S IVD, kit, clottingA collection of reagents and other associated materials intended to be used for the quantitative measurement of protein S in a clinical specimen, using a clotting method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
956610125
Device count
1
Kit
true
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
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
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
00843876000602CRYOcheck Factor VIII ChromogenicPrecision Biologic IncGGP2025-11-25
00630414320366BC von Willebrand ReagentSiemens Healthcare Diagnostics Products GmbHGGP2024-09-12
00842768018800BC von Willebrand ReagentSiemens Healthcare Diagnostics Products GmbHGGP2024-09-12
00195226001129HemosIL Chromogenic Factor IXINSTRUMENTATION LABORATORY COMPANYGGP2024-07-09
00630414640433vWF AgSiemens Healthcare Diagnostics Products GmbHGGP2024-03-29
00630414639437Berichrom a2-AntiplasminSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414639628Berichrom Protein CSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414639710Berichrom Protein CSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414639826INNOVANCE Free PS AgSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414640389Factor VIII Chromogenic AssaySiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414640457Protein S AcSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414640655Protein C ReagentSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00842768006661vWF AgSiemens Healthcare Diagnostics Products GmbHGGP2023-06-16
00843876000565CRYOcheck Chromogenic Factor IXPrecision Biologic IncGGP2023-01-06
G0561012580Lyophilized Platelets Bio/Data CorporationGGP2022-03-23
G0561012691vW Normal Reference PlasmaBio/Data CorporationGGP2022-03-23
G0561012701vW Abnormal Control PlasmaBio/Data CorporationGGP2022-03-23
G0561015951Lyophilized Platelets Bio/Data CorporationGGP2022-03-23
G0561030251vW Factor Assay (Ristocetin Cofactor)Bio/Data CorporationGGP2022-03-23
G0561064261vW Normal Control PlasmaBio/Data CorporationGGP2022-03-23
G0561067301vW Select Kit (Ristocetin Cofactor)Bio/Data CorporationGGP2022-03-23
00843876000558CRYOcheck Factor VIII ChromogenicPrecision Biologic IncGGP2020-07-27
08600000686048VFERamco Laboratories, Inc.GGP2019-03-26
00843876000503CRYOcheck™ FVIII Inhibitor KitPrecision Biologic IncGGP2019-03-25
00842768039522INNOVANCE Free PS AgSiemens Healthcare Diagnostics Products GmbHGGP2018-11-15
03607450007374STA® - Staclot® Protein C 3DIAGNOSTICA STAGOGGP2017-12-06
10629009010000VisuLize Factor FVIII Antigen KitAffinity Biologicals IncGGP2017-04-28
10629009020009VisuLize Factor FIX Antigen KitAffinity Biologicals IncGGP2017-04-28
00811476010000Chrono-logCHRONO-LOG CORPGGP2016-10-11
00811476010017Chrono-logCHRONO-LOG CORPGGP2016-10-11