Other products from "TEM INNOVATIONS GMBH"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 04260160470587 delta System (US/CA) 201001 The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively. GGN,JPA Plasma, Coagulation Control,System, Multipurpose For In Vitro Coagulation Studies 2 ROTEM®
2 04260160470372 sigma 211000 The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system in The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses.Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected. JPA System, Multipurpose For In Vitro Coagulation Studies 2 ROTEM®
3 04260160470358 sigma ROTROL P 555202 The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system in The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses.Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected. JPA System, Multipurpose For In Vitro Coagulation Studies 2 ROTEM®
4 04260160470341 sigma ROTROL N 555201 The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system in The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses.Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected. JPA System, Multipurpose For In Vitro Coagulation Studies 2 ROTEM®
5 04260160470327 sigma complete + hep 555502 The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system in The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses.Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected. JPA System, Multipurpose For In Vitro Coagulation Studies 2 ROTEM®
6 04260160470112 ROTROL P 503-25-US, 503-25 ROTROL P is a quality control material for monitoring accuracy and precision of ROTROL P is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM® delta Thromboelastometry System. For in vitro diagnostic use only. GGN,JPA Plasma, Coagulation Control,System, Multipurpose For In Vitro Coagulation Studies ROTEM®
7 04260160470105 ROTROL N 503-24-US, 503-24 ROTROL N is a quality control material for monitoring accuracy and precision of ROTROL N is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM® delta Thromboelastometry System. For in vitro diagnostic use only. JPA,GGN System, Multipurpose For In Vitro Coagulation Studies,Plasma, Coagulation Control ROTEM®
8 04260160470099 star-tem® 20 503-10-US The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environ-ment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve – clot firmness over time) and several defined numerical parameters describing the curve quantitatively.The star-tem® reagent is intended for use as recalcification reagent in the NATEM and INTEM assay on the ROTEM® delta. The corresponding assays are described in the NATEM assay application sheet and in the Instructions for Use of the in-tem® reagent (REF 503-02-US), resp. GGN,JPA Plasma, Coagulation Control,System, Multipurpose For In Vitro Coagulation Studies ROTEM®
9 04260160470082 hep-tem® 503-09-US The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environ-ment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.The hep-tem® assay is a semi-quantitative in vitro diagnostic assay used to inactivate heparin in patients receiving unfractionated heparin on the ROTEM® delta. To monitor the coagulation process citrated whole blood specimens are used. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). JPA,GGN System, Multipurpose For In Vitro Coagulation Studies,Plasma, Coagulation Control ROTEM®
10 04260160470075 fib-tem® 503-06-US The FIBTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® The FIBTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the clot firmness of citrated whole blood specimens after blocking platelet contribution to the clot firmness. fib-tem® is always used in conjunction with ex-tem®. Clotting characteristics are described by the functional parameter Clot Firmness (A20/MCF). JPA System, Multipurpose For In Vitro Coagulation Studies ROTEM®
11 04260160470068 ap-tem® 503-04-US The APTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® d The APTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the clot firmness of citrated whole blood specimens after blocking hyperfibrinolysis by aprotinin. ap-tem® is always used in conjunction with ex-tem®. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). CFT and alpha (Speed of Clot Formation) are complementary parameters and should be used in conjunction with the main parameters Clotting Time (CT) and Clot Firmness (A20/MCF). JPA System, Multipurpose For In Vitro Coagulation Studies ROTEM®
12 04260160470044 in-tem® 503-02-US The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.The in-tem® assay is a semi-quantitative in vitro diagnostic assay used to monitor the coagulation process via the intrinsic pathway in citrated whole blood specimens on the ROTEM® delta. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). GGN,JPA Plasma, Coagulation Control,System, Multipurpose For In Vitro Coagulation Studies ROTEM®
13 04260160470020 delta System 200100-US The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively. JPA,GGN System, Multipurpose For In Vitro Coagulation Studies,Plasma, Coagulation Control 2 ROTEM®
Other products with the same Product Code "JPA"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 G0561025161 102516 102516 Lupus Anticoagulant Confirmation Reagent BIO/DATA CORPORATION
2 04260160470587 delta System (US/CA) 201001 The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively. ROTEM® TEM INNOVATIONS GMBH
3 04260160470372 sigma 211000 The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system in The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses.Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected. ROTEM® TEM INNOVATIONS GMBH
4 04260160470358 sigma ROTROL P 555202 The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system in The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses.Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected. ROTEM® TEM INNOVATIONS GMBH
5 04260160470341 sigma ROTROL N 555201 The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system in The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses.Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected. ROTEM® TEM INNOVATIONS GMBH
6 04260160470327 sigma complete + hep 555502 The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system in The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses.Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected. ROTEM® TEM INNOVATIONS GMBH
7 04260160470242 ex-tem® 503-05-US The EXTEM assay is a semi-quantitative in vitro diagnostic assay used to monitor The EXTEM assay is a semi-quantitative in vitro diagnostic assay used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM® delta. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). CFT and alpha (Speed of Clot Formation) are complementary parameters and should be used in conjunction with the main parameters Clotting Time (CT) and Clot Firmness (A20/MCF). ROTEM® TEM INNOVATIONS GMBH
8 04260160470112 ROTROL P 503-25-US, 503-25 ROTROL P is a quality control material for monitoring accuracy and precision of ROTROL P is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM® delta Thromboelastometry System. For in vitro diagnostic use only. ROTEM® TEM INNOVATIONS GMBH
9 04260160470105 ROTROL N 503-24-US, 503-24 ROTROL N is a quality control material for monitoring accuracy and precision of ROTROL N is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM® delta Thromboelastometry System. For in vitro diagnostic use only. ROTEM® TEM INNOVATIONS GMBH
10 04260160470099 star-tem® 20 503-10-US The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environ-ment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve – clot firmness over time) and several defined numerical parameters describing the curve quantitatively.The star-tem® reagent is intended for use as recalcification reagent in the NATEM and INTEM assay on the ROTEM® delta. The corresponding assays are described in the NATEM assay application sheet and in the Instructions for Use of the in-tem® reagent (REF 503-02-US), resp. ROTEM® TEM INNOVATIONS GMBH
11 04260160470082 hep-tem® 503-09-US The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environ-ment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.The hep-tem® assay is a semi-quantitative in vitro diagnostic assay used to inactivate heparin in patients receiving unfractionated heparin on the ROTEM® delta. To monitor the coagulation process citrated whole blood specimens are used. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). ROTEM® TEM INNOVATIONS GMBH
12 04260160470075 fib-tem® 503-06-US The FIBTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® The FIBTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the clot firmness of citrated whole blood specimens after blocking platelet contribution to the clot firmness. fib-tem® is always used in conjunction with ex-tem®. Clotting characteristics are described by the functional parameter Clot Firmness (A20/MCF). ROTEM® TEM INNOVATIONS GMBH
13 04260160470068 ap-tem® 503-04-US The APTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® d The APTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the clot firmness of citrated whole blood specimens after blocking hyperfibrinolysis by aprotinin. ap-tem® is always used in conjunction with ex-tem®. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). CFT and alpha (Speed of Clot Formation) are complementary parameters and should be used in conjunction with the main parameters Clotting Time (CT) and Clot Firmness (A20/MCF). ROTEM® TEM INNOVATIONS GMBH
14 04260160470044 in-tem® 503-02-US The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.The in-tem® assay is a semi-quantitative in vitro diagnostic assay used to monitor the coagulation process via the intrinsic pathway in citrated whole blood specimens on the ROTEM® delta. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). ROTEM® TEM INNOVATIONS GMBH
15 04260160470020 delta System 200100-US The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively. ROTEM® TEM INNOVATIONS GMBH
16 03607450590272 59027 STA R Max® (with cap piercing option) DIAGNOSTICA STAGO
17 03607450590265 59026 STA R Max® DIAGNOSTICA STAGO
18 03607450590135 59013 STA R Max® DIAGNOSTICA STAGO
19 03607450590104 59010 STA R Max® (with cap piercing option) DIAGNOSTICA STAGO
20 03607450589900 58990 STA Compact Max® DIAGNOSTICA STAGO
21 03607450589894 58989 STA Compact Max® (with cap piercing option) DIAGNOSTICA STAGO
22 03607450589795 58979 STA-R Evolution® Expert Series (with cap piercing option) DIAGNOSTICA STAGO
23 03607450589788 58978 STA-R Evolution® Expert Series DIAGNOSTICA STAGO
24 03607450581041 58104 STA Satellite® DIAGNOSTICA STAGO
25 00842768026812 10487098 ORKL19 Standard Human Plasma for the calibration of coagulation and fibrinolysis tests Standard Human Plasma SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
26 00842768024887 10458677 OVKF032 The BFT II Analyzer is a semi-automated device intended for use to determine PT, The BFT II Analyzer is a semi-automated device intended for use to determine PT, APTT and Fibrinogen BFT II Analyzer SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
27 00842768017742 10446684 OWZC39 Washing Solution is used for cleaning the Siemens Healthcare Diagnostics coagula Washing Solution is used for cleaning the Siemens Healthcare Diagnostics coagulation analyzers Washing Solution for Coagulation Analyzers SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
28 00842768014222 10446232 ORHO37 Supplementary Reagent for coagulation tests Calcium Chloride Solution SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
29 00842768012358 10446541 OVMN11 The cuvettes serve coagulation tests as a reaction vessel. Cuvettes for BFT // Analyzer SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
30 00842768012259 10446530 OVKG03 The cuvettes serve coagulation tests as a reaction vessel. BFT II Analyzer Dispo System SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
31 00842768006869 10445989 OPCC03 For calibration of the Berichrom Heparin assay for measurement of unfractionated heparin Berichrom® Heparin UF Calibrator SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
32 00842768006845 10445987 OPCA03 For calibration of the Berichrom Heparin assay for measurement of low molecular For calibration of the Berichrom Heparin assay for measurement of low molecular weight heparin Berichrom® Heparin LMW Calibrator SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
33 00817869020311 SC-125, SC-126, H2O Hemotec Whole Blood Control Kit Large ANALYTICAL CONTROL SYSTEMS INC
34 00817869020274 SC-127 SC-127 Whole Blood Control Level III ANALYTICAL CONTROL SYSTEMS INC
35 00817869020267 SC-126 SC-126 Whole Blood Control Level II ANALYTICAL CONTROL SYSTEMS INC
36 00817869020250 SC-125 SC-125 Whole Blood Control Level I ANALYTICAL CONTROL SYSTEMS INC
37 00817869020007 CR-109 CR-109 .02M Calcium Chloride ANALYTICAL CONTROL SYSTEMS INC
38 00673978519173 550-90 CONTROL TEST 550-90 PROFICIENCY 5L NA MEDTRONIC, INC.
39 00613994615633 313-51 DEVICE 313-51 HEPTRAC ELEC QLT CNTRL CEM HEPtrac® MEDTRONIC, INC.
40 B55890013181 900-1318 900-1318 The Reference Plasma Quality Control Kit is for use with the Sonoclot® Analyzer The Reference Plasma Quality Control Kit is for use with the Sonoclot® Analyzer System to verify performance of activated cuvettes. Testing should be performed prior to the use of a new shipment of activated cuvettes and monthly throughout use of the stock. More frequent testing may be required to comply with local, state and federal QC requirements. Reference plasma quality control is important to properly verify proper performance of coagulation test activators. A two level testing approach is used to perform quality control of the activator used in an activated coagulation test. Level I is run with the activator on the reference plasma. Level II is run with the non-activated test on the reference plasma. These two tests confirm the effectiveness of the activator to perform its intended coagulation activation.Each Kit contains:1 vial Reference Plasma Control - 6 ml vial containing a lyophilized preparation of citrated animal plasma, stabilizers and buffer. Contains no human material.1 vial Distilled Water - 6 ml vial containing 5.0 ml laboratory grade distilled water.1 vial 0.02 M Calcium Chloride - 6 ml vial containing 5.0 ml 0.02 M Calcium Chloride.5 plastic 1 ml syringes2 non-activated test cuvettes (blue with clear caps, stir bars, and probes) Sonoclot® Reference Plasma Quality Control Kit SIENCO, INC.
41 B55890013021 900-1302 900-1302 The Reference Viscosity Oil QC test is a simple means of verifying proper operat The Reference Viscosity Oil QC test is a simple means of verifying proper operation of the Sonoclot Analyzer. This test consists of a two point verification of the electromechanical oscillator and also ensures that the heating control is operating accurately. The two verification points are: 1) Probe-In-Air, and 2) Probe-In-Oil. The Probe-In-Air is the response of the electromechanical oscillator to air. The Probe-In-Oil is the response of the electromechanical oscillator to the reference viscosity liquid. Since the viscosity of the reference viscosity fluid is significantly temperature dependent, the Probe-In-Oil test point also verifies the temperature regulation. The QC test should be run each day the Sonoclot Analyzer is used or as required by your institution. Each Reference Viscosity Quality Control Kit contains 24 cuvettes, 24 probes, 1 vial of reference viscosity oil with end cap, and these instructions. These supplies provide 24 QC tests for the analyzer. Sonoclot® Reference Viscosity Oil Quality Control Kit SIENCO, INC.
42 B55880004321 800-0432 800-0432 The SonACT Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coag The SonACT Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The SonACT test is a celite activated whole blood clotting time test. It may also be used with citrated whole blood and plasma. The SonACT Kit is intended for general purpose global hemostasis monitoring including: clot detection, fibrin formation, platelet function, and hyperfibrinolysis. The monitoring information is typically used for anticoagulant management up to high heparin levels (0 to approximately 6 units per ml), hypercoagulable and/or hypocoagulable screening, platelet function assessment, and hyperfibrinolysis screening. When used with the Sonoclot Analyzer System, the SonACT test provides quantitative Onset/ACT and Clot Rate results as well as qualitative and quantitative information on the Sonoclot Signature including: fibrin formation, platelet function, and hyperfibrinolysis.Each kit contains 100 lidded colorless plastic activation cuvettes, 100 probes, and instructions for use. The activation cuvettes contain a controlled amount of celite and a magnetic stir bar. Sonoclot® SonACT Kit SIENCO, INC.
43 B55880004311 800-0431 800-0431 The SonACT Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coag The SonACT Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The SonACT test is a celite activated whole blood clotting time test. It may also be used with citrated whole blood and plasma. The SonACT Kit is intended for general purpose global hemostasis monitoring including: clot detection, fibrin formation, platelet function, and hyperfibrinolysis. The monitoring information is typically used for anticoagulant management up to high heparin levels (0 to approximately 6 units per ml), hypercoagulable and/or hypocoagulable screening, platelet function assessment, and hyperfibrinolysis screening. When used with the Sonoclot Analyzer System, the SonACT test provides quantitative Onset/ACT and Clot Rate results as well as qualitative and quantitative information on the Sonoclot Signature including: fibrin formation, platelet function, and hyperfibrinolysis.Each kit contains 24 lidded colorless plastic activation cuvettes, 24 probes, and instructions for use. The activation cuvettes contain a controlled amount of celite and a magnetic stir bar. Sonoclot® SonACT Kit SIENCO, INC.
44 B55880004261 800-0426 800-0426 The Non-Activated Clotting Test Kit contains the necessary components for an in The Non-Activated Clotting Test Kit contains the necessary components for an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. It may be used with native whole blood, citrated whole blood, and plasma. The Non-Activated Kit may either be used as a non-activated clotting test or as a general use test with user provided activators. It is intended for customer designed hemostasis monitoring on the Sonoclot Analyzer. The Non-Activated cuvette allows for coagulation monitoring using tissue activation, thrombin activation, and other custom activators. Some of the applications for the Non-Activated test with the addition of customer determined reagents are monitoring of fibrin formation, fibrinolysis, hyperfibrinolysis and clot retraction. When used with the Sonoclot Analyzer System, the Non-Activated test provides quantitative Onset/ACT and Clot Rate results as well as qualitative and quantitative information on the Sonoclot Signature including: fibrin formation, platelet function, and hyperfibrinolysis. Each kit contains 24 lidded plastic cuvettes, 24 probes, and instructions for use. The cuvettes contain a magnetic stir bar. Sonoclot® NonActivated Kit SIENCO, INC.
45 B55880004251 800-0425 800-0425 The Non-Activated Clotting Test Kit contains the necessary components for an in The Non-Activated Clotting Test Kit contains the necessary components for an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. It may be used with native whole blood, citrated whole blood, and plasma. The Non-Activated Kit may either be used as a non-activated clotting test or as a general use test with user provided activators. It is intended for customer designed hemostasis monitoring on the Sonoclot Analyzer. The Non-Activated cuvette allows for coagulation monitoring using tissue activation, thrombin activation, and other custom activators. Some of the applications for the Non-Activated test with the addition of customer determined reagents are monitoring of fibrin formation, fibrinolysis, hyperfibrinolysis and clot retraction. When used with the Sonoclot Analyzer System, the Non-Activated test provides quantitative Onset/ACT and Clot Rate results as well as qualitative and quantitative information on the Sonoclot Signature including: fibrin formation, platelet function, and hyperfibrinolysis. Each kit contains 100 lidded plastic cuvettes, 100 probes, and instructions for use. The cuvettes contain a magnetic stir bar. Sonoclot® NonActivated Kit SIENCO, INC.
46 B55880004011 800-0401 800-0401 The kACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulat The kACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The kACT test is a kaolin activated whole blood clotting time test. It may also be used with citrated whole blood and plasma. The kACT Kit is intended for high dose heparin management with or without aprotinin. The kACT test provides quantitative Onset/ACT and Clot Rate results with the Sonoclot Analyzer. The kACT test is not intended for platelet function monitoring. Each kit contains 24 lidded blue plastic activation cuvettes, 24 probes, and instructions for use. The activation cuvettes contain a controlled amount of kaolin and a magnetic stir bar. Sonoclot® kACT Kit SIENCO, INC.
47 B55880004001 800-0400 800-0400 The kACT Kit is an in vitro diagnostic test for use with the Sonoclot Coagulatio The kACT Kit is an in vitro diagnostic test for use with the Sonoclot Coagulation & Platelet Function Analyzer System. The kACT test is a kaolin activated whole blood clotting time test. It may also be used with citrated whole blood and plasma.The kACT kit is intended for high dose heparin management with or without aprotinin. The kACT test provides quantitative Onset/ACT and Clot Rate results with the Sonoclot Analyzer. The kACT test is not intended for platelet function monitoring.Each kACT Kit contains 100 lidded blue plastic activation cuvettes, 100 probes, and instructions for use. The activation cuvettes contain a controlled amount of kaolin and a magnetic stir bar. Sonoclot® kACT Kit SIENCO, INC.
48 30812747018412 07-066 TEG ANALYZER 5000, 230V, 60HZ, FG TEG5000 HEMOSTASIS ANALYZER HAEMONETICS CORPORATION
49 30812747018184 07-022 TEG ANALYZER, 5000, 120V, 60HZ, FG TEG5000 HEMOSTASIS ANALYZER HAEMONETICS CORPORATION
50 20812747018132 6211 DISPOSABLE CUPS & PINS, CLEAR TEG5000 HEMOSTASIS SYSTEM HAEMONETICS CORPORATION