No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 20711234303082 | TFT50I | TFT50I | Tenderfoot Toddler Heel Stick Device 50/box | JCA | Device, Bleeding Time | Tenderfoot Toddler Heel Stick Device | |
2 | 10711234170359 | 000DCGACT-2 | 000DCGACT-2 | directCHECK GH100 ACT+L2 15/box | GGN | Plasma, Coagulation Control | 2 | directCHECK ACT+ Whole Blood Control, Level 2 |
3 | 20711234312022 | TFM50I | TFM50I | Tenderfoot Micro-Preemie Heel Stick Device 50/box | JCA | Device, Bleeding Time | Tenderfoot Micro-Preemie Heel Stick Device | |
4 | 10711234540107 | J-1001 | J-1001 | Temperature Verification Cartridge | JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | Hemochron Whole Blood Microcoagulation System |
5 | 10711234540091 | JEA-QC | JEA-QC | Electronic System Verification - Abnormal | JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | Hemochron Whole Blood Microcoagulation System |
6 | 10711234540084 | JEN-QC | JEN-QC | Electronic System Verification - Normal | JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | Hemochron Whole Blood Microcoagulation System |
7 | 10711234540077 | HE-J04 | HE-J04 | Electronic System Verification Kit | JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | Hemochron Whole Blood Microcoagulation System |
8 | 10711234540039 | RPM-CD | RPM-CD | Report Maker V6.01 | JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | Hemochron Whole Blood Microcoagulation System |
9 | 10711234510070 | ELITEL | ELITEL | Hemochron Whole Blood Microcoagulation System - Hemochron Signature Elite Instru Hemochron Whole Blood Microcoagulation System - Hemochron Signature Elite Instrument (Loaner) | JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | Hemochron Whole Blood Microcoagulation System |
10 | 10711234510056 | ELITEDEMO | ELITEDEMO | Hemochron Whole Blood Microcoagulation System - Hemochron Signature Elite Instru Hemochron Whole Blood Microcoagulation System - Hemochron Signature Elite Instrument (Demonstration) | JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | Hemochron Whole Blood Microcoagulation System |
11 | 10711234510025 | ELITERF | ELITERF | Hemochron Whole Blood Microcoagulation System - Hemochron Signature Elite Instru Hemochron Whole Blood Microcoagulation System - Hemochron Signature Elite Instrument Refurbished | JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | Hemochron Whole Blood Microcoagulation System |
12 | 10711234510018 | ELITE | ELITE | Hemochron Whole Blood Microcoagulation System - Hemochron Signature Elite Instrument | JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | Hemochron Whole Blood Microcoagulation System |
13 | 10711234103081 | JACT-LR | JACT-LR | ACT-Low Range Cuvettes - 45 cuvettes/box. | JBP | Activated Whole Blood Clotting Time | Hemochron Whole Blood Microcoagulation System | |
14 | 10711234103067 | JACT+ | JACT+ | ACT+ Cuvette - 45 cuvettes/box. | JBP | Activated Whole Blood Clotting Time | Hemochron Whole Blood Microcoagulation System | |
15 | 10711234103043 | J201C | J201C | Citrate PT Cuvette - 45 test cuvettes/box. | GJS | Test, Time, Prothrombin | Hemochron Whole Blood Microcoagulation System | |
16 | 10711234103036 | J201 | J201 | PT Cuvette - 45 test cuvettes/box. | GJS | Test, Time, Prothrombin | Hemochron Whole Blood Microcoagulation System | |
17 | 10711234103029 | J103C | J103C | Citrate APTT Cuvette - 45 test cuvettes/box. | GFO | Activated Partial Thromboplastin | Hemochron Whole Blood Microcoagulation System | |
18 | 10711234103012 | J103 | J103 | APTT Cuvette - 45 test cuvettes/box | JPA | System, Multipurpose For In Vitro Coagulation Studies | Hemochron Whole Blood Microcoagulation System | |
19 | 20711234311032 | SUP100I | SUP100I | Surgicutt Bleeding Time Blotting Paper 100/box | FRL | Fiber, Medical, Absorbent | Surgicutt Bleeding Time Blotting Paper | |
20 | 20711234301194 | TF200I | TF200I | Tenderfoot Newborn Heel Stick Device 200/box | JCA | Device, Bleeding Time | Tenderfoot Newborn Heel Stick Device | |
21 | 20711234301187 | TF1000I | TF1000I | Tenderfoot Newborn Heel Stick Device 1000/box | JCA | Device, Bleeding Time | Tenderfoot Newborn Heel Stick Device | |
22 | 20711234301163 | TF50I | TF50I | Tenderfoot Newborn Heel Stick Device 50/box | JCA | Device, Bleeding Time | Tenderfoot Newborn Heel Stick Device | |
23 | 10711234530160 | AVOX1000ERF | AVOX1000ERF | Avoximeter Whole Blood Oximeter System - Instrument Refurbished | DQA | Oximeter | 2 | Avoximeter Whole Blood Oximeter |
24 | 10711234530153 | AVOX1000ED | AVOX1000ED | Avoximeter Whole Blood Oximeter System - Instrument (Demonstration) | DQA | Oximeter | 2 | Avoximeter Whole Blood Oximeter |
25 | 10711234530146 | AVOX1000EL | AVOX1000EL | Avoximeter Whole Blood Oximeter System - Instrument (Loaner) | DQA | Oximeter | 2 | Avoximeter Whole Blood Oximeter |
26 | 10711234530023 | AVOX1000E | AVOX1000E | Avoximeter Whole Blood Oximeter System - Instrument | DQA | Oximeter | 2 | Avoximeter Whole Blood Oximeter |
27 | 10711234160022 | C100B | C100B | Avoximeter 1000E Cuvettes 100 cuvettes/box | DQA | Oximeter | Avoximeter Whole Blood Oximeter | |
28 | 10711234160015 | E-QCYO | E-QCYO | Avoximeter Whole Blood Oximeter Optical QC Filters | DQA | Oximeter | 2 | Avoximeter Whole Blood Oximeter |
29 | 20711234302160 | TFP200I | TFP200I | Tenderfoot Preemie Heel Stick Device 200/box | JCA | Device, Bleeding Time | Tenderfoot Preemie Heel Stick Device | |
30 | 20711234302153 | TFP1000I | TFP1000I | Tenderfoot Preemie Heel Stick Device 1000/box | JCA | Device, Bleeding Time | Tenderfoot Preemie Heel Stick Device | |
31 | 20711234302139 | TFP50I | TFP50I | Tenderfoot Preemie Heel Stick Device 50/box | JCA | Device, Bleeding Time | Tenderfoot Preemie Heel Stick Device | |
32 | 10711234515044 | 000GH100L | 000GH100L | GEM Hemochron 100 System (Loaner) | JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | GEM Hemochron 100 System |
33 | 10711234515006 | 000GH100 | 000GH100 | GEM Hemochron 100 System - GEM Hemochron 100 Instrument | JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | GEM Hemochron 100 System |
34 | 10711234170373 | 000DCGLR-2 | 000DCGLR-2 | directCHECK GH100 ACTLR2 15/box | GGN | Plasma, Coagulation Control | 2 | directCHECK ACT-LR Whole Blood Control, Level 2 |
35 | 10711234103401 | 000GACT+ | 000GACT+ | GH100 ACT+ 45 cuvettes/box. | JBP | Activated Whole Blood Clotting Time | 2 | GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+) |
36 | 20711234308186 | TL5000I | TL5000I | Tenderlett Finger Incision Device 5000/box | FMK | Lancet, Blood | Tenderlett Finger Incision Device | |
37 | 20711234308162 | TL100I | TL100I | Tenderlett Finger Incision Device 100/box | FMK | Lancet, Blood | Tenderlett Finger Incision Device | |
38 | 20711234304157 | SU50I | SU50I | Surgicutt Bleeding Time Device 50/box | JCA | Device, Bleeding Time | Surgicutt Bleeding Time Device | |
39 | 10711234540121 | 000GCCM | 000GCCM | Centralized Configuration Manager Software | JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | Centralized Configuration Manager Software |
40 | 10711234500170 | 86000RF | 86000RF | VerifyNow System (Refurbished) | JOZ | System, Automated Platelet Aggregation | 2 | VerifyNow System |
41 | 10711234500163 | 86000D | 86000D | VerifyNow System (Demonstration) | JOZ | System, Automated Platelet Aggregation | 2 | VerifyNow System |
42 | 10711234500156 | 86000L | 86000L | VerifyNow System (Loaner) | JOZ | System, Automated Platelet Aggregation | 2 | VerifyNow System |
43 | 10711234500149 | 86003D | 86003D | VerifyNow System (Demonstration) | JOZ | System, Automated Platelet Aggregation | 2 | VerifyNow System |
44 | 10711234500132 | 86003L | 86003L | VerifyNow System (Loaner) | JOZ | System, Automated Platelet Aggregation | 2 | VerifyNow System |
45 | 10711234500118 | 86003 | 86003 | VerifyNow System (Serviced) | JOZ | System, Automated Platelet Aggregation | 2 | VerifyNow System |
46 | 10711234500095 | 85021 | 85021 | VerifyNow Printer Kit | JOZ | System, Automated Platelet Aggregation | 2 | VerifyNow System |
47 | 10711234500040 | 86000 | 86000 | VerifyNow System | JOZ | System, Automated Platelet Aggregation | 2 | VerifyNow System |
48 | 10711234170366 | 000DCGLR-1 | 000DCGLR-1 | directCHECK GH100 ACTLRL1 15/box. | GGN | Plasma, Coagulation Control | 2 | directCHECK ACT-LR Whole Blood Controls, Level 1 |
49 | 10711234170342 | 000DCGACT-1 | 000DCGACT-1 | directCHECK GH100 ACT+L1 15/box | GGN | Plasma, Coagulation Control | 2 | directCHECK ACT+ Whole Blood Control Level 1 |
50 | 10711234150122 | 70068 | 70068 | VerifyNow System Electronic Quality Control Device | JOZ | System, Automated Platelet Aggregation | 2 | VerifyNow System |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 08426950965572 | 00000880311R | 00000880311R | ACL ELITE (Refurbished) | ACL ELITE | INSTRUMENTATION LABORATORY COMPANY |
2 | 08426950639725 | 3710-0344 | BIO-FLASH | BIO-FLASH | BIOKIT, S.A. | |
3 | 08426950585039 | 0009802204 | 0009802204 | HemosIL AcuStar Cleaning Solution | HemosIL AcuStar Cleaning Solution | INSTRUMENTATION LABORATORY COMPANY |
4 | 08426950574255 | 00097579000 | 00097579000 | HemosIL Chromogenic Optic test 160umol L | Chromogenic Optic 160 umol L | INSTRUMENTATION LABORATORY COMPANY |
5 | 08426950553502 | 00020302500 | 00020302500 | HemosIL Rinse Solution 2L (ACLFutura Advance) | HemosIL Rinse Solution (ACLFutura Advance) | INSTRUMENTATION LABORATORY COMPANY |
6 | 08426950515395 | 0020302400 | 00020302400 | HemosIL Rinse Solution 4L (ACL TOP Family) | HemosIL Rinse Solution (ACL TOP Family) | INSTRUMENTATION LABORATORY COMPANY |
7 | 08426950498001 | 0009801000 | 0009801000 | ACL AcuStar | HemosIL AcuStar | INSTRUMENTATION LABORATORY COMPANY |
8 | 08426950497042 | 0009802201 | 0009802201 | HemosIL AcuStar Triggers | HemosIL AcuStar Triggers | INSTRUMENTATION LABORATORY COMPANY |
9 | 08426950497035 | 0009802200 | 0009802200 | HemosIL AcuStar System Rinse | HemosIL AcuStar System Rinse | INSTRUMENTATION LABORATORY COMPANY |
10 | 08426950453482 | 00001000311R | 00001000311R | ACL ELITE PRO (Refurbished) | ACL ELITE PRO | INSTRUMENTATION LABORATORY COMPANY |
11 | 08426950453062 | 00020011000 | 00020011000 | HemosIL Special Test Control Level 1 | HemosIL Special Test Control Level 1 | INSTRUMENTATION LABORATORY COMPANY |
12 | 08426950453017 | 00000880311 | 00000880311 | ACL ELITE | ACL ELITE | INSTRUMENTATION LABORATORY COMPANY |
13 | 08426950452805 | 00009758080 | 00009758080 | COAGULOMETRIC OPTIC TEST, ACL FUTURA | Coagulation Optic (Advance) | INSTRUMENTATION LABORATORY COMPANY |
14 | 08426950452775 | 00009757950 | 00009757950 | HemosIL Chromogenic Optic Test Kit | Chromogenic Optic | INSTRUMENTATION LABORATORY COMPANY |
15 | 08426950452768 | 00009757980 | 00009757980 | KIT,CHROM OPTIC TEST 160MMOL L,FUTU ADVA | Chromogenic Optic (Advance) | INSTRUMENTATION LABORATORY COMPANY |
16 | 08426950452034 | 00009758050 | 00009758050 | HemosIL Coagulation Optic Test | Coagulation Optic | INSTRUMENTATION LABORATORY COMPANY |
17 | 08426950451570 | 00001000311 | 00001000311 | ACL ELITE PRO | ACL ELITE PRO | INSTRUMENTATION LABORATORY COMPANY |
18 | 08426950442189 | 00020012000 | 00020012000 | HemosIL Special Test Control Level 2 | HemosIL Special Test Control Level 2 | INSTRUMENTATION LABORATORY COMPANY |
19 | 08426950088608 | 06260040000 | 06260040000 | GEM Test ACT-LR Cartridges | GEM Test ACT-LR Cartridges | INSTRUMENTATION LABORATORY COMPANY |
20 | 08426950088585 | 06260038000 | 06260038000 | GEM Test ACT+ Cartridges | GEM Test ACT+ Cartridges | INSTRUMENTATION LABORATORY COMPANY |
21 | 08426950088561 | 06260034000 | 06260034000 | GEM Test APTT Cartridges | GEM Test APTT Cartridges | INSTRUMENTATION LABORATORY COMPANY |
22 | 08426950088554 | 06260032000 | 06260032000 | GEM Test Citrate PT Cartridges | GEM Test Citrate PT Cartridges | INSTRUMENTATION LABORATORY COMPANY |
23 | 08426950088530 | 06260030000 | 06260030000 | GEM Test PT Cartridges | GEM Test PT Cartridges | INSTRUMENTATION LABORATORY COMPANY |
24 | 08426950088523 | 06260020000 | 06260020000 | Electronic Verification Cartridge Kit | Electronic Verification Cartridge Kit | INSTRUMENTATION LABORATORY COMPANY |
25 | 08426950088516 | 06260019000 | 06260019000 | Temperature Verification Cartridges | Temperature Verification Cartridges | INSTRUMENTATION LABORATORY COMPANY |
26 | 08426950078944 | 00020002400 | 00020002400 | HemosIL Wash-R Emulsion 1000 mL | HemosIL Wash-R Emulsion | INSTRUMENTATION LABORATORY COMPANY |
27 | 08426950075882 | 00020009700 | 00020009700 | HemosIL Rinse Solution (ACL TOP Family) 4000 mL | HemosIL Rinse Solution (ACL TOP Family) | INSTRUMENTATION LABORATORY COMPANY |
28 | 08426950026549 | 0009832700 | 0009832700 | Critical Care/HemosIL Cleaning Agent (Clean B) | HemosIL Cleaning Agent (Clean B) | INSTRUMENTATION LABORATORY COMPANY |
29 | 08426950003151 | 00006800000 | 00006800000 | Rotors 100 pcs 2000 wells | Rotors 100 pcs 2000 wells | INSTRUMENTATION LABORATORY COMPANY |
30 | 08426950003083 | 00020009320 | 00020009320 | HemosIL Rinse Solution (ACL Futura Advance) 2 LIT | HemosIL Rinse Solution (ACL Futura Advance) | INSTRUMENTATION LABORATORY COMPANY |
31 | 05391521421081 | M01000 | Destiny MAX Analyzer | TCOAG IRELAND LIMITED | ||
32 | 05391521421029 | H01000P | Destiny Plus | TCOAG IRELAND LIMITED | ||
33 | 05391521421012 | N04000 | KC® 4 Delta | TCOAG IRELAND LIMITED | ||
34 | 05391521421005 | G05000 | KC® 1 Delta | TCOAG IRELAND LIMITED | ||
35 | 04987562433735 | BV981798 | CS-2500 COMPLETE | Automated Blood Coagulation Analyzer CS-2500 | SYSMEX CORPORATION | |
36 | 04987562425686 | BR142626 | Automated Blood Coagulation Analyzer CA-620 | Automated Blood Coagulation Analyzer CA-600 series CA-620 | SYSMEX CORPORATION | |
37 | 04987562425426 | BY990757 | CS-5100 COMPLETE | Automated Blood Coagulation Analyzer CS-5100 | SYSMEX CORPORATION | |
38 | 04987562409471 | 06372511 | CS-2100i COMPLETE | Automated Blood Coagulation Analyzer CS-2100i | SYSMEX CORPORATION | |
39 | G0561025161 | 102516 | 102516 | Lupus Anticoagulant Confirmation Reagent | BIO/DATA CORPORATION | |
40 | 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 |
41 | 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 |
42 | 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 |
43 | 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 |
44 | 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 |
45 | 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 |
46 | 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 |
47 | 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 |
48 | 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 |
49 | 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 |
50 | 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 |