No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00842768039416 | 10873440 | B4265-37 | For coagulation tests and as a rinsing solution for the sample needles of the Sy For coagulation tests and as a rinsing solution for the sample needles of the Sysmex® CA Systems | KQJ | SYSTEM, FIBRINOGEN DETERMINATION | Dade® CA System Buffer | |
2 | 00842768028441 | 10385332 | LKPM | For use in daily maintenance of the IMMULITE® and IMMULITE® 1000 systems | JJQ | COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE | 1 | IMMULITE® Probe Cleaning Kit |
3 | 00842768028427 | 10385231 | L2PWSM | For use in the routine operation of the IMMULITE® 2000 and IMMULITE® 2500 Analyzers | JJQ | COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE | IMMULITE 2000/XPi Probe Wash Module | |
4 | 00842768017872 | 10446691 | OWZG23 | Quantitative determination of fibrinogen in plasma | KQJ | SYSTEM, FIBRINOGEN DETERMINATION | Multifibren® U | |
5 | 00842768017865 | 10446689 | OWZG19 | Quantitative determination of fibrinogen in plasma | KQJ | SYSTEM, FIBRINOGEN DETERMINATION | Multifibren® U | |
6 | 00842768017087 | 10873532 | OPOD05 | For quality control of the INNOVANCE® Heparin assay | GGN | Plasma, coagulation control | INNOVANCE Heparin UF Control 2 | |
7 | 00842768016134 | 10446085 | OQIO19 | N/T Protein Control SL/M is a medium level, multi-analyte control for use as acc N/T Protein Control SL/M is a medium level, multi-analyte control for use as accuracy and precision control in the determination of human serum proteins by immunonephelometry with the BN Systems | JJY | Multi-analyte controls, all kinds (assayed) | N/T Protein Control SL/M | |
8 | 00842768016110 | 10446089 | OQIP19 | N/T Protein Control SL/H is a high level, multi-analyte control for use as accur N/T Protein Control SL/H is a high level, multi-analyte control for use as accuracy and precision control in the determination of human serum proteins by immunonephelometry with the BN Systems | JJY | Multi-analyte controls, all kinds (assayed) | N/T Protein Control SL/H | |
9 | 00842768013065 | 10446632 | OWMG15 | Quantitative determination of thrombin/antithrombin III complex (TAT) in human plasma | JBQ | ANTITHROMBIN III QUANTITATION | 2 | Enzygnost® TAT micro |
10 | 00842768012945 | 10446620 | OWLD11 | Determination of heparin activity in plasma and for the monitoring of heparin therapy | KFF | ASSAY, HEPARIN | 2 | Berichrom® Heparin |
11 | 00842768011030 | 10446415 | OTXY13 | For the determination of the activity of coagulation factor X in human plasma by For the determination of the activity of coagulation factor X in human plasma by coagulometric methods | GJT | PLASMA, COAGULATION FACTOR DEFICIENT | Coagulation Factor X Deficient Plasma | |
12 | 00842768009976 | 10446316 | OSDF13 | For the determination of the activity of coagulation factor XI in human plasma b For the determination of the activity of coagulation factor XI in human plasma by coagulometric methods | GJT | PLASMA, COAGULATION FACTOR DEFICIENT | Coagulation Factor XI Deficient Plasma | |
13 | 00842768009761 | 10446295 | OSAR19 | Quantitative determination of IgA in human serum and plasma on BN Systems | CFN | METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M) | 2 | N Antisera to Human IgA |
14 | 00842768009747 | 10446293 | OSAR11 | Quantitative determination of IgA in human serum and plasma on BN Systems | CFN | METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M) | 2 | N Antisera to Human IgA |
15 | 00842768008153 | 10446136 | OQUB21 | Cleaning solution BN II, BN ProSpec® Systems and BCS® Systems | JZW | NEPHELOMETER | Cleaner SCS | |
16 | 00842768008054 | 10446127 | OQTC11 | Quantitative determination of soluble transferrin receptor (sTfR) in human serum Quantitative determination of soluble transferrin receptor (sTfR) in human serum and heparinized plasma on BN Systems | DDG | TRANSFERRIN, ANTIGEN, ANTISERUM, CONTROL | N Latex sTfR | |
17 | 00842768007477 | 10461887 | OQGP15 | LA 1 Screening Reagent. Simplified DRVV reagent to screen for the presence of Lu LA 1 Screening Reagent. Simplified DRVV reagent to screen for the presence of Lupus Anticoagulants | GIR | REAGENT, RUSSEL VIPER VENOM | LA 1 Screening Reagent | |
18 | 00842768007279 | 10446043 | OQDC13 | Assayed control for RF ASL and CRP assays on Siemens Systems | JJY | Multi-analyte controls, all kinds (assayed) | N/T Rheumatology Control SL/2 | |
19 | 00842768006876 | 10445990 | OPCD03 | For use as a low level assayed control for the quantitative measurement of low m For use as a low level assayed control for the quantitative measurement of low molecular weight heparin with Berichrom Heparin | GIZ | PLASMA, CONTROL, NORMAL | Berichrom® Heparin LMW Control 1 | |
20 | 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 | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | Berichrom® Heparin LMW Calibrator | |
21 | 00842768006838 | 10445986 | OPBZ03 | For use as a high level assayed control for the quantitative measurement of unfr For use as a high level assayed control for the quantitative measurement of unfractionated heparin with Berichrom Heparin | GGC | CONTROL, PLASMA, ABNORMAL | Berichrom® Heparin UF Control 2 | |
22 | 00842768006715 | 10445973 | OPAX03 | Quantitative determination of homocysteine in human serum and plasma on BN II an Quantitative determination of homocysteine in human serum and plasma on BN II and BN ProSpec® Systems | LPS | URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM | 2 | N Latex HCY |
23 | 00842768006388 | 10445924 | KC735 | CYSC CON L is an assayed intralaboratory quality control for assessment of preci CYSC CON L is an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of the CYSC method on the Dimension Vista® System | JJY | Multi-analyte controls, all kinds (assayed) | DImension Vista® Cystatin C Control L (low) | |
24 | 00842768006340 | 10445920 | KC716 | PROT1 CON M is an assayed, mid-level, intralaboratory, multi-analyte quality con PROT1 CON M is an assayed, mid-level, intralaboratory, multi-analyte quality control for the assessment of precision and analytical bias on the Dimension Vista® System | JJY | Multi-analyte controls, all kinds (assayed) | DImension Vista® Protein 1 Control M (medium) | |
25 | 00842768004056 | 10445731 | B4244-10 | For use as control in citrated coagulation systems | GGC | CONTROL, PLASMA, ABNORMAL | Dade® Ci-Trol® Coagulation Control Level 1 | |
26 | 00842768006173 | 10445902 | K7054 | For the quantitative measurement of immunoglobulin E in human serum and plasma ( For the quantitative measurement of immunoglobulin E in human serum and plasma (heparin or EDTA) on the Dimension Vista® System | DGC | IGE, ANTIGEN, ANTISERUM, CONTROL | DImension Vista® Immunoglobulin E Flex® reagent cartridge | |
27 | 00842768006135 | 10445898 | K7046 | For the quantitative measurement of C-reactive protein in human serum and plasma For the quantitative measurement of C-reactive protein in human serum and plasma on the Dimension Vista® System | NQD | CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL | Dimension Vista hsCRP Flex reagent cartridge | |
28 | 00842768006128 | 10445897 | K7044 | For the quantitative measurement of total homocysteine in human serum and plasma For the quantitative measurement of total homocysteine in human serum and plasma on the Dimension Vista® System | LPS | URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM | DImension Vista® Homocysteine Flex® reagent cartridge | |
29 | 00842768003967 | 10445722 | B4233-60 | The DIMERTEST® Latex Assay is intended for the rapid qualitative or semiquantita The DIMERTEST® Latex Assay is intended for the rapid qualitative or semiquantitative evaluation of circulating derivatives of cross-linked fibrin degradation products (XL-FDP) in human plasma | DAP | FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL | 2 | Dade® DIMERTEST® Latex Assay |
30 | 00842768003929 | 10445718 | B4233-15SY | Quantitative determination of fibrinogen in human plasma | GFK | FIBRINOGEN DETERMINATION STANDARDS AND CONTROLS | 2 | Dade® Fibrinogen Determination Reagents |
31 | 00842768003905 | 10445716 | B4224-60 | Control in heparin assay procedures | KFF | ASSAY, HEPARIN | Dade® Ci-Trol® Heparin Control, High | |
32 | 00842768003899 | 10445715 | B4224-50 | Control in heparin assay procedures | KFF | ASSAY, HEPARIN | Dade® Ci-Trol® Heparin Control, Low | |
33 | 00630414992617 | 10459382 | B4132-1A | For differential staining in hematology that gives results similar to a Wright-G For differential staining in hematology that gives results similar to a Wright-Giemsa stain | KQC | STAINS, HEMATOLOGY | 1 | Diff-Quik™ Stain Set |
34 | 00630414285054 | 10873691 | OWTI15 | Quantitative determination of ADNase B in human serum on BN Systems | GTR | ANTIDEOXYRIBONUCLEASE, STREPTOCOCCUS SPP. | 1 | N Latex ADNase B (USA) |
35 | 00630414284996 | 10873685 | OQDC17 | Assayed control for RF, ASL and CRP assays on BN Systems | JJY | Multi-analyte controls, all kinds (assayed) | 1 | N/T Rheumatology Control SL/2 |
36 | 00630414237503 | 10873663 | OPJF05 | Assayed accuracy and precision controls in the determination of free light chain Assayed accuracy and precision controls in the determination of free light chains (FLC) type kappa and type lambda on BN Systems. | JJY | Multi-analyte controls, all kinds (assayed) | N FLC CONTROL SL2 | |
37 | 00630414237480 | 10873661 | OPJE05 | Assayed accuracy and precision controls in the determination of free light chain Assayed accuracy and precision controls in the determination of free light chains (FLC) type kappa and type lambda on BN Systems. | JJY | Multi-analyte controls, all kinds (assayed) | N FLC CONTROL SL1 | |
38 | 00630414023526 | 10873571 | B4233-17SY | Quantitative determination of fibrinogen in human plasma | GFK | FIBRINOGEN DETERMINATION STANDARDS AND CONTROLS | 2 | Dade® Fibrinogen Determination Reagents |
39 | 00630414002736 | 10465217 | OVLI012 | The BN ProSpec® is a system for the quantitative determination of proteins in se The BN ProSpec® is a system for the quantitative determination of proteins in serum, plasma, urine and CSF | JZW | NEPHELOMETER | 1 | BN ProSpec® System |
40 | 00842768028410 | 10385393 | LPWS2 | For use in the routine operation of the IMMULITE® and IMMULITE® 1000 Analyzers | JJQ | COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE | IMMULITE® Probe Wash Module | |
41 | 00842768018534 | 10445997 | OPCS05 | Quantitative determination of carbohydrate-deficient transferrin (CDT) in human Quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum on BN II and BN ProSpec® Systems | NAO | Test,carbohydrate deficient transferrin | 1 | N Latex CDT Kit |
42 | 00842768014222 | 10446232 | ORHO37 | Supplementary Reagent for coagulation tests | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | Calcium Chloride Solution | |
43 | 00842768013478 | 10446673 | OWWR17 | Determination of the functional activity of antithrombin III (AT III) in human plasma | JPE | ANTITHROMBIN III, TWO STAGE CLOTTING TIME ASSAY | 2 | Berichrom® Antithrombin III (A) |
44 | 00842768013461 | 10446672 | OWWR15 | Determination of the functional activity of antithrombin III (AT III) in human plasma | JPE | ANTITHROMBIN III, TWO STAGE CLOTTING TIME ASSAY | 2 | Berichrom® Antithrombin III (A) |
45 | 00842768012778 | 10446604 | OWHU21 | Qualitative detection or semi-quantitative determination of C-reactive protein ( Qualitative detection or semi-quantitative determination of C-reactive protein (CRP) in human serum | DCN | SYSTEM, TEST, C-REACTIVE PROTEIN | 2 | RapiTex® CRP |
46 | 00842768012686 | 10446595 | OWHG13 | Quantitative determination of Ig light chains, type kappa in human serum on BN Systems | DFH | KAPPA, ANTIGEN, ANTISERUM, CONTROL | 2 | N Antiserum to Human-Ig/L-chain, K-type |
47 | 00842768012297 | 10446534 | OVLC21 | The N Evaporation Cap 2.5ml is part of the BN ProSpec system. | JZW | NEPHELOMETER | N Evaporation Caps for Control Vials (2.5 mL) | |
48 | 00842768012174 | 10446521 | OVIC11 | The N Predilution Well is used for settings of dilutions of standards, controls and sera. | DEW | IGG, ANTIGEN, ANTISERUM, CONTROL | N Predilution Wells | |
49 | 00842768011443 | 10446458 | OUMU15 | Supplementary reagent for multiple protein assays on Siemens systems | CFN | METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M) | 2 | N Supplementary Reagent/Precipitation |
50 | 00842768011085 | 10446420 | OUAX41 | Qualitative detection or semi-quantitative determination of C-reactive protein ( Qualitative detection or semi-quantitative determination of C-reactive protein (CRP) in human serum | DCN | SYSTEM, TEST, C-REACTIVE PROTEIN | 2 | RapiTex® CRP |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 05391521421081 | M01000 | Destiny MAX Analyzer | TCOAG IRELAND LIMITED | ||
2 | 05391521421029 | H01000P | Destiny Plus | TCOAG IRELAND LIMITED | ||
3 | 05391521421012 | N04000 | KC® 4 Delta | TCOAG IRELAND LIMITED | ||
4 | 05391521421005 | G05000 | KC® 1 Delta | TCOAG IRELAND LIMITED | ||
5 | 04987562433735 | BV981798 | CS-2500 COMPLETE | Automated Blood Coagulation Analyzer CS-2500 | SYSMEX CORPORATION | |
6 | 04987562425686 | BR142626 | Automated Blood Coagulation Analyzer CA-620 | Automated Blood Coagulation Analyzer CA-600 series CA-620 | SYSMEX CORPORATION | |
7 | 04987562425426 | BY990757 | CS-5100 COMPLETE | Automated Blood Coagulation Analyzer CS-5100 | SYSMEX CORPORATION | |
8 | 04987562409471 | 06372511 | CS-2100i COMPLETE | Automated Blood Coagulation Analyzer CS-2100i | SYSMEX CORPORATION | |
9 | G0561025161 | 102516 | 102516 | Lupus Anticoagulant Confirmation Reagent | BIO/DATA CORPORATION | |
10 | 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 |
11 | 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 |
12 | 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 |
13 | 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 |
14 | 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 |
15 | 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 |
16 | 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 |
17 | 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 |
18 | 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 |
19 | 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 |
20 | 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 |
21 | 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 |
22 | 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 |
23 | 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 |
24 | 03607450590272 | 59027 | STA R Max® (with cap piercing option) | DIAGNOSTICA STAGO | ||
25 | 03607450590265 | 59026 | STA R Max® | DIAGNOSTICA STAGO | ||
26 | 03607450590135 | 59013 | STA R Max® | DIAGNOSTICA STAGO | ||
27 | 03607450590104 | 59010 | STA R Max® (with cap piercing option) | DIAGNOSTICA STAGO | ||
28 | 03607450589900 | 58990 | STA Compact Max® | DIAGNOSTICA STAGO | ||
29 | 03607450589894 | 58989 | STA Compact Max® (with cap piercing option) | DIAGNOSTICA STAGO | ||
30 | 03607450589795 | 58979 | STA-R Evolution® Expert Series (with cap piercing option) | DIAGNOSTICA STAGO | ||
31 | 03607450589788 | 58978 | STA-R Evolution® Expert Series | DIAGNOSTICA STAGO | ||
32 | 03607450581041 | 58104 | STA Satellite® | DIAGNOSTICA STAGO | ||
33 | 00842768026812 | 10487098 | ORKL19 | Standard Human Plasma for the calibration of coagulation and fibrinolysis tests | Standard Human Plasma | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
34 | 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 |
35 | 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 |
36 | 00842768014222 | 10446232 | ORHO37 | Supplementary Reagent for coagulation tests | Calcium Chloride Solution | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
37 | 00842768012358 | 10446541 | OVMN11 | The cuvettes serve coagulation tests as a reaction vessel. | Cuvettes for BFT // Analyzer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
38 | 00842768012259 | 10446530 | OVKG03 | The cuvettes serve coagulation tests as a reaction vessel. | BFT II Analyzer Dispo System | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
39 | 00842768006869 | 10445989 | OPCC03 | For calibration of the Berichrom Heparin assay for measurement of unfractionated heparin | Berichrom® Heparin UF Calibrator | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
40 | 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 |
41 | 00817869020311 | SC-125, SC-126, H2O | Hemotec Whole Blood Control Kit Large | ANALYTICAL CONTROL SYSTEMS INC | ||
42 | 00817869020274 | SC-127 | SC-127 | Whole Blood Control Level III | ANALYTICAL CONTROL SYSTEMS INC | |
43 | 00817869020267 | SC-126 | SC-126 | Whole Blood Control Level II | ANALYTICAL CONTROL SYSTEMS INC | |
44 | 00817869020250 | SC-125 | SC-125 | Whole Blood Control Level I | ANALYTICAL CONTROL SYSTEMS INC | |
45 | 00817869020007 | CR-109 | CR-109 | .02M Calcium Chloride | ANALYTICAL CONTROL SYSTEMS INC | |
46 | 00673978519173 | 550-90 | CONTROL TEST 550-90 PROFICIENCY 5L | NA | MEDTRONIC, INC. | |
47 | 00613994615633 | 313-51 | DEVICE 313-51 HEPTRAC ELEC QLT CNTRL CEM | HEPtrac® | MEDTRONIC, INC. | |
48 | 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. |
49 | 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. |
50 | 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. |