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Panels › Hematology › Product code GJS · Class 2

Test, Time, Prothrombin

Regulation 864.7750

0510(k)s in 12 months (127 all time)
0recalls in 12 months (73 all time)
68recalls that name a 510(k)
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Top companies in GJS

DateFirm and productCodeLinked 510(k)
Mar 31, 2025Fisher Diagnostics
Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
Open, Classified
GJSK994100
Mar 31, 2025Fisher Diagnostics
Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.
Open, Classified
GJSK994100
Aug 26, 2022Mckesson Medical-Surgical Inc. Corporate Office
a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test (PT/INR) Whole Blood Sample 50 Tests-IVD. Part No. 0356-50. b. Coagulation Control Kit Coag-Sense PT / INR T
Open, Classified
GJSK093243
K183255
Apr 8, 2022Instrumentation Laboratory
HemosIL ReadiPlasTin, Part No. 0020301400
Open, Classified
GJSK122584
Nov 23, 2021Instrumentation Laboratory
HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
Open, Classified
GJSK122584
Jan 7, 2021Roche Diagnostics Operations, Inc.
CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin. Catalog 04837738001
Terminated
GJSK062925
Jan 7, 2021Roche Diagnostics Operations, Inc.
CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Catalog: 04837975001 Units could cons
Terminated
GJSK060978
Feb 1, 2019TERRIFIC CARE LLC
CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and
Terminated
GJSNone listed
Nov 2, 2018Roche Diagnostics Corporation
CoaguChek XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strips, Catalog Number: 04625374160; CoaguChek XS PT Test 24 Tests, Cat
Terminated
GJSK071041
K093460 +2
Aug 1, 2018Instrumentation Laboratory Co.
Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the qu
Terminated
GJSK122584
Jul 24, 2018Diagnostica Stago, Inc.
Diagnostica Stago STA Noplastine CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. REF: 00666 The STA - Noplastine CI kits provide reagents for the determ
Terminated
GJSK922565
Jul 24, 2018Diagnostica Stago, Inc.
Diagnostica Stago STA Noplastine CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA - Noplastine CI Plus kits provide reagents fo
Terminated
GJSK922040
Mar 3, 2018Instrumentation Laboratory Co.
Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
Terminated
GJSK122584
Oct 25, 2017Diagnostica Stago, Inc.
STA - Neoplastine Cl Plus (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).
Terminated
GJSK922040
Oct 25, 2017Diagnostica Stago, Inc.
STA - Neoplastine Cl (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).
Terminated
GJSK922565
Oct 25, 2017Diagnostica Stago, Inc.
Neoplastine Cl Plus (ref. 00375) Product Usage: Manual or automated determination of the prothrombin time (PT).
Terminated
GJSK922040
Oct 25, 2017Diagnostica Stago, Inc.
Neoplastine Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).
Terminated
GJSK922040
Aug 19, 2016Alere San Diego, Inc.
Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5, 99008G7 Product Usage: The Alere INRatio/INRatio2 system uses
Terminated
GJSK092987
Aug 19, 2016Alere San Diego, Inc.
Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usage: The INRatio/INRatio2 Test Strips perform a modified version of the one-stage Prothrombin Time test, using a recombinant
Terminated
GJSK092987
Aug 19, 2016Alere San Diego, Inc.
Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usage: The Alere INRatio/INRatio2 system uses a modified version of the one-stage PT test. After a drop of blood is a
Terminated
GJSK072727
Aug 19, 2016Alere San Diego, Inc.
Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting of the INRa
Terminated
GJSK110212
Aug 19, 2016Alere San Diego, Inc.
Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting
Terminated
GJSK110212
Aug 19, 2016Alere San Diego, Inc.
Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Product Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, c
Terminated
GJSK072727
Aug 19, 2016Alere San Diego, Inc.
Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. T
Terminated
GJSK020679
Aug 19, 2016Alere San Diego, Inc.
INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Product Usage: The INRatio Prothrombin Time Monitoring System uses a modified version of the one-stage PT test. After a drop of
Terminated
GJSK020679
Aug 19, 2016Alere San Diego, Inc.
Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product Usage: Alere INRatio 2 PT/INR Monitoring System (Professional Use): The Alere INRatio 2 PT/INR Monitoring System (Professiona
Terminated
GJSK110212
Aug 10, 2015Abbott Point Of Care Inc.
i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one per pouch. There are 24 cartridges packed in a box. a prothrombin time test useful in monitoring pati
Terminated
GJSK020355
Jan 3, 2015Alere San Diego, Inc.
INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere INRatio 2 PT/INR Home Monitoring System - 0200433 Alere INRatio 2 PT/INR Home Monitoring System - 020045
Terminated
GJSK072727
K092987 +1
Jan 3, 2015Alere San Diego, Inc.
INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio Prothrombin Time (PT) Monitoring System - 0100137 Alere INRatio Replacement Monitor The test systems contain indi
Terminated
GJSK020679
K021923 +1
Jan 3, 2015Alere San Diego, Inc.
Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio PT/INR Test Strips, Box of 12 - 0100139 Alere INRatio PT/INR Test Strips, Box of 48 The test strips
Terminated
GJSK020679
K021923 +3
Dec 19, 2014Instrumentation Laboratory Co.
HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determinati
Terminated
GJSK060931
May 8, 2014Alere San Diego, Inc.
Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring System (Professional Use), consisting of the Monitor and test strip, is used for quantitativ
Terminated
GJSK092987
Dec 4, 2013Abbott Point Of Care Inc.
Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as C
Terminated
GJSK020355
Sep 13, 2013Assuramed
ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouched cuvettes refrigerated 2-8C (36 - 36F); MATERIALS PROVIDED; ProTime cuvettes with Tenderlett Plus; or; Prot
Terminated
GJSK010599
Jul 22, 2013Instrumentation Laboratory Co.
HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy.
Terminated
GJSK070005
Jun 24, 2013Roche Diagnostics Operations, Inc.
CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.
Terminated
GJSK060978
Jun 24, 2013Roche Diagnostics Operations, Inc.
CoaguChek XS Plus System The CoaguChek XS Plus system for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.
Terminated
GJSK071041
Jun 24, 2013Roche Diagnostics Operations, Inc.
CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood fr
Terminated
GJSK093460
Jun 24, 2013Roche Diagnostics Operations, Inc.
CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medicatio
Terminated
GJSK062925
Apr 15, 2013Roche Diagnostics Operations, Inc.
CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time ("PT").
Terminated
GJSK093460
Feb 19, 2013International Technidyne Corp.
Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50. International Technidyne Corporation. The Pro Time Microcoagulation System is a portable battery operated instrume
Terminated
GJSK010599
Aug 8, 2012Abbott Point Of Care Inc.
I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.
Terminated
GJSK020355
Jun 24, 2011Alere San Diego
0200086, Triad Alcohol Prep Pads, 100 box 0200432, Alcohol Prep Pads, packaged in the Alere INRatio 2 PT/INR Home Monitoring Kit; or Hemosense INRatio 2 Prothrombin Time/lNR Testing Kit, Self-Test Sys
Terminated
GJSK092987
Oct 6, 2010Fisher Diagnostics, A Company of Fisher Scientific LLC
Pacific Hemostasis Thromboplastin-DS, catalog #100354, packaged in 4 mL lypholyzed vials, 10 bottles/carton. Vials are labeled, in part ***Fisher Diagnostics a division of Fisher Scientific Company,
Terminated
GJSK940082
Jul 13, 2010Abbott Point of Care Inc.
i-STAT PT/INR Cartridge Abbott Point of Care, Princeton, NJ
Terminated
GJSK020355
Sep 3, 2009Roche Diagnostics Operations, inc.
Roche CoaguChek XS System, CoaguChek XS Plus Care Kit, Roche Diagnostics, Indianapolis, IN; Model Number 05021537001. CoaguChek XS System and CoaguChek XS Plus System are point of care monitoring dev
Terminated
GJSK071041
Sep 3, 2009Roche Diagnostics Operations, inc.
Roche CoaguChek XS System, CoaguChek XS PST Kit, Roche Diagnostics, Indianapolis, IN; Catalog/Model Number 04837738001. CoaguChek XS System and CoaguChek XS Plus System are point of care monitoring d
Terminated
GJSK062925
Sep 3, 2009Roche Diagnostics Operations, inc.
Roche CoaguChek XS System, CoaguChek XS Professional Care Kit, Roche Diagnostics, Indianapolis, IN; Catalog/Model Number 04837975001. CoaguChek XS System and CoaguChek XS Plus System are point of ca
Terminated
GJSK060978
Aug 11, 2009Roche Diagnostics Corp.
Roche Coaguchex XS Systems for Patient Self-Testing, Roche Diagnostics, Indianapolis, IN; REF 04837738001 includes the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indian
Terminated
GJSK062925
May 22, 2009HemoSense Inc
HemoSense INRatio2 Prothrombin Time Monitor, manufactured by HemoSense Incorporated. The INRatio2 PT Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capi
Terminated
GJSK072727

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