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 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). JPA 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 Codes "GGN, JPA"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00850201006208 840C 840C ACTICLOT Protein C Resistance control plasmas BIOMEDICA ADI INC.
2 00847661004516 27102X 27102X Liquichek D-dimer Control MiniPak (A processed human plasma assayed D-dimer control.) Liquichek BIO-RAD LABORATORIES, INC.
3 00847661004509 27103 27103 Liquichek D-dimer Control Level 3 (A processed human plasma assayed D-dimer control.) Liquichek BIO-RAD LABORATORIES, INC.
4 00847661004493 27102 27102 Liquichek D-dimer Control Level 2 (A processed human plasma assayed D-dimer control.) Liquichek BIO-RAD LABORATORIES, INC.
5 00847661004486 27101 27101 Liquichek D-dimer Control Level 1 (A processed human plasma assayed D-dimer control.) Liquichek BIO-RAD LABORATORIES, INC.
6 00847661004479 27100 27100 Liquichek D-dimer Control Level Low (A processed human plasma assayed D-dimer control.) Liquichek BIO-RAD LABORATORIES, INC.
7 00847661001959 745X 745X Lyphochek Coagulation Control Level Trilevel MiniPak (A human plasma coagulatio Lyphochek Coagulation Control Level Trilevel MiniPak (A human plasma coagulation control.) Lyphochek BIO-RAD LABORATORIES, INC.
8 00847661001898 598X 598X Lyphochek Hemostasis Control MiniPak (A human plasma hemostasis control.) Lyphochek BIO-RAD LABORATORIES, INC.
9 00847661001041 599 599 Lyphochek Hemostasis Control Level 3 (A human plasma hemostasis control.) Lyphochek BIO-RAD LABORATORIES, INC.
10 00847661001034 598 598 Lyphochek Hemostasis Control Level 2 (A human plasma hemostasis control.) Lyphochek BIO-RAD LABORATORIES, INC.
11 00847661001027 597 597 Lyphochek Hemostasis Control Level 1 (A human plasma hemostasis control.) Lyphochek BIO-RAD LABORATORIES, INC.
12 00847661000792 746 746 Lyphochek Coagulation Control Level 3 (A human plasma coagulation control.) Lyphochek BIO-RAD LABORATORIES, INC.
13 00847661000785 745 745 Lyphochek Coagulation Control Level 2 (A human plasma coagulation control.) Lyphochek BIO-RAD LABORATORIES, INC.
14 00847661000778 744 744 Lyphochek Coagulation Control Level 1 (A human plasma coagulation control.) Lyphochek BIO-RAD LABORATORIES, INC.
15 00845275000832 100603 Thermo Scientific Pacific Hemostasis® FISHER DIAGNOSTICS
16 00845275000818 100560 Thermo Scientific Pacific Hemostasis® FISHER DIAGNOSTICS
17 00845275000689 100013 Thermo Scientific Pacific Hemostasis® FISHER DIAGNOSTICS
18 00845275000658 100312 Thermo Scientific Pacific Hemostasis® FISHER DIAGNOSTICS
19 00845275000634 100308 Thermo Scientific Pacific Hemostasis® FISHER DIAGNOSTICS
20 00845275000610 100607 Thermo Scientific Pacific Hemostasis® FISHER DIAGNOSTICS
21 00845275000603 100604 Thermo Scientific Pacific Hemostasis® FISHER DIAGNOSTICS
22 00845275000504 100301 Thermo Scientific Pacific Hemostasis® FISHER DIAGNOSTICS
23 00843876000541 CCLN-05 CCLN-05 Prepared from human source plasma and recommended as a negative control in assay Prepared from human source plasma and recommended as a negative control in assays for lupus anticoagulant. CRYOcheck Lupus Negative Control PRECISION BIOLOGIC INC
24 00843876000534 CCLN-10 CCLN-10 Prepared from human source plasma and recommended as a negative control in assay Prepared from human source plasma and recommended as a negative control in assays for lupus anticoagulant. CRYOcheck Lupus Negative Control PRECISION BIOLOGIC INC
25 00843876000503 CCIK08 The CRYOcheck FVIII Inhibitor Kit is for clinical laboratory use in conjunction The CRYOcheck FVIII Inhibitor Kit is for clinical laboratory use in conjunction with a factor VIII activity assay to enable performance of a modified Nijmegen-Bethesda assay using 3.2% citrated human plasma. It enables the determination of a functional FVIII inhibitor titer to aid in the clinical management of congenital hemophilia A in individuals aged 2 years and older. CRYOcheck™ FVIII Inhibitor Kit PRECISION BIOLOGIC INC
26 00843876000206 CCNRP-10 CRYOcheck™ Normal Reference Plasma PRECISION BIOLOGIC INC
27 00843876000190 CCNRP-05 CRYOcheck™ Normal Reference Plasma PRECISION BIOLOGIC INC
28 00843876000183 APCR-05 CRYOcheck™ APCR Positive Control PRECISION BIOLOGIC INC
29 00843876000152 CCLP-10 CRYOcheck™ Lupus Positive Control PRECISION BIOLOGIC INC
30 00843876000145 CCLP-05 CRYOcheck™ Lupus Positive Control PRECISION BIOLOGIC INC
31 00843876000138 CCLF-10 CRYOcheck™ Low Fibrinogen Control PRECISION BIOLOGIC INC
32 00843876000114 CCA2-10 00843876010113 CRYOcheck™ Abnormal 2 Control PRECISION BIOLOGIC INC
33 00843876000107 CCA1-10 CRYOcheck™ Abnormal 1 Control PRECISION BIOLOGIC INC
34 00843876000091 ARP2-10 CRYOcheck™ Abnormal 2 Reference Control PRECISION BIOLOGIC INC
35 00843876000084 ARP1-10 CRYOcheck™ Abnormal 1 Reference Control PRECISION BIOLOGIC INC
36 00843876000077 ARP1-05 CRYOcheck™ Abnormal 1 Reference Control PRECISION BIOLOGIC INC
37 00843876000046 CCN-40 CRYOcheck™ Pooled Normal Plasma PRECISION BIOLOGIC INC
38 00843876000039 CCN10-10 CRYOcheck™ Pooled Normal Plasma PRECISION BIOLOGIC INC
39 00843876000022 CCN-15 CRYOcheck™ Pooled Normal Plasma PRECISION BIOLOGIC INC
40 00843876000015 CCN-10 CRYOcheck™ Pooled Normal Plasma PRECISION BIOLOGIC INC
41 00842768026812 10487098 ORKL19 Standard Human Plasma for the calibration of coagulation and fibrinolysis tests Standard Human Plasma SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
42 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
43 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
44 00842768017100 10873534 OPOE05 For quality control of the INNOVANCE® Heparin assay INNOVANCE Heparin LMW Control 1 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
45 00842768017094 10873533 OPOF05 For quality control of the INNOVANCE® Heparin assay INNOVANCE Heparin LMW Control 2 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
46 00842768017087 10873532 OPOD05 For quality control of the INNOVANCE® Heparin assay INNOVANCE Heparin UF Control 2 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
47 00842768017070 10873531 OPOC05 For quality control of the INNOVANCE® Heparin assay INNOVANCE Heparin UF Control 1 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
48 00842768014222 10446232 ORHO37 Supplementary Reagent for coagulation tests Calcium Chloride Solution SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
49 00842768012358 10446541 OVMN11 The cuvettes serve coagulation tests as a reaction vessel. Cuvettes for BFT // Analyzer SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
50 00842768012259 10446530 OVKG03 The cuvettes serve coagulation tests as a reaction vessel. BFT II Analyzer Dispo System SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH