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)
Top companies in GJS
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2025 | Fisher Diagnostics Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays. Open, Classified |
GJS | K994100 |
| Mar 31, 2025 | Fisher Diagnostics Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays. Open, Classified |
GJS | K994100 |
| Aug 26, 2022 | Mckesson 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 |
GJS | K093243 K183255 |
| Apr 8, 2022 | Instrumentation Laboratory HemosIL ReadiPlasTin, Part No. 0020301400 Open, Classified |
GJS | K122584 |
| Nov 23, 2021 | Instrumentation Laboratory HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent. Open, Classified |
GJS | K122584 |
| Jan 7, 2021 | Roche 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 |
GJS | K062925 |
| Jan 7, 2021 | Roche 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 |
GJS | K060978 |
| Feb 1, 2019 | TERRIFIC 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 |
GJS | None listed |
| Nov 2, 2018 | Roche 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 |
GJS | K071041 K093460 +2 |
| Aug 1, 2018 | Instrumentation 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 |
GJS | K122584 |
| Jul 24, 2018 | Diagnostica 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 |
GJS | K922565 |
| Jul 24, 2018 | Diagnostica 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 |
GJS | K922040 |
| Mar 3, 2018 | Instrumentation Laboratory Co. Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400 Terminated |
GJS | K122584 |
| Oct 25, 2017 | Diagnostica Stago, Inc. STA - Neoplastine Cl Plus (ref. 00606)
Product Usage:
Manual or automated determination of the prothrombin time (PT). Terminated |
GJS | K922040 |
| Oct 25, 2017 | Diagnostica Stago, Inc. STA - Neoplastine Cl (ref. 00605)
Product Usage:
Manual or automated determination of the prothrombin time (PT). Terminated |
GJS | K922565 |
| Oct 25, 2017 | Diagnostica Stago, Inc. Neoplastine Cl Plus (ref. 00375)
Product Usage:
Manual or automated determination of the prothrombin time (PT). Terminated |
GJS | K922040 |
| Oct 25, 2017 | Diagnostica Stago, Inc. Neoplastine Cl Plus @ (ref.00374)
Product Usage:
Manual or automated determination of the prothrombin time (PT). Terminated |
GJS | K922040 |
| Aug 19, 2016 | Alere 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 |
GJS | K092987 |
| Aug 19, 2016 | Alere 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 |
GJS | K092987 |
| Aug 19, 2016 | Alere 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 |
GJS | K072727 |
| Aug 19, 2016 | Alere 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 |
GJS | K110212 |
| Aug 19, 2016 | Alere 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 |
GJS | K110212 |
| Aug 19, 2016 | Alere 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 |
GJS | K072727 |
| Aug 19, 2016 | Alere 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 |
GJS | K020679 |
| Aug 19, 2016 | Alere 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 |
GJS | K020679 |
| Aug 19, 2016 | Alere 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 |
GJS | K110212 |
| Aug 10, 2015 | Abbott 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 |
GJS | K020355 |
| Jan 3, 2015 | Alere 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 |
GJS | K072727 K092987 +1 |
| Jan 3, 2015 | Alere 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 |
GJS | K020679 K021923 +1 |
| Jan 3, 2015 | Alere 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 |
GJS | K020679 K021923 +3 |
| Dec 19, 2014 | Instrumentation 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 |
GJS | K060931 |
| May 8, 2014 | Alere 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 |
GJS | K092987 |
| Dec 4, 2013 | Abbott 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 |
GJS | K020355 |
| Sep 13, 2013 | Assuramed 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 |
GJS | K010599 |
| Jul 22, 2013 | Instrumentation 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 |
GJS | K070005 |
| Jun 24, 2013 | Roche 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 |
GJS | K060978 |
| Jun 24, 2013 | Roche 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 |
GJS | K071041 |
| Jun 24, 2013 | Roche 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 |
GJS | K093460 |
| Jun 24, 2013 | Roche 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 |
GJS | K062925 |
| Apr 15, 2013 | Roche 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 |
GJS | K093460 |
| Feb 19, 2013 | International 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 |
GJS | K010599 |
| Aug 8, 2012 | Abbott 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 |
GJS | K020355 |
| Jun 24, 2011 | Alere 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 |
GJS | K092987 |
| Oct 6, 2010 | Fisher 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 |
GJS | K940082 |
| Jul 13, 2010 | Abbott Point of Care Inc. i-STAT PT/INR Cartridge
Abbott Point of Care, Princeton, NJ Terminated |
GJS | K020355 |
| Sep 3, 2009 | Roche 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 |
GJS | K071041 |
| Sep 3, 2009 | Roche 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 |
GJS | K062925 |
| Sep 3, 2009 | Roche 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 |
GJS | K060978 |
| Aug 11, 2009 | Roche 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 |
GJS | K062925 |
| May 22, 2009 | HemoSense 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 |
GJS | K072727 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.