| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00812747010057 | 4.x.x | NextGen version 4.x.x | MMH | SOFTWARE, BLOOD BANK, STAND ALONE PRODUCTS | 2 | NextGen | |
| 2 | 10812747018159 | 01-097 | PIPETTE KIT, 1000UL | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 2 | TEG5000 | |
| 3 | 30812747013875 | 08150-110-E | MCS+ (RBC), LIST NO 08150-110-E | GKT | Separator, automated, blood cell, diagnostic | 2 | MCS+ | |
| 4 | 30812747018412 | 07-066 | TEG ANALYZER 5000, 230V, 60HZ, FG | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 2 | TEG5000 HEMOSTASIS ANALYZER | |
| 5 | 30812747018184 | 07-022 | TEG ANALYZER, 5000, 120V, 60HZ, FG | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 2 | TEG5000 HEMOSTASIS ANALYZER | |
| 6 | 00812747010101 | 3.x.x | SafeTrace Tx version 3.x.x | MMH | Blood Establishment Computer Software and Accessories | 2 | SafeTrace Tx | |
| 7 | 00812747010033 | 4.x.x | SafeTrace Tx version 4.x.x | MMH | Blood Establishment Computer Software and Accessories | 2 | SafeTrace Tx | |
| 8 | 30812747013851 | 08150-220-E | MCS+ (RBC), LIST NO 08150-220-E | GKT | Separator, automated, blood cell, diagnostic | 2 | MCS+ | |
| 9 | 30812747011673 | 0694S-00 | Plasma Bottles with Saline Adapter | KSR | CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS | Haemonetics® PCS®2 & NexSys PCS™ Systems | ||
| 10 | 20887691002872 | 732-37M | Transfer Bag 1000 ml w/Y Set | KSR | CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS | 2 | Haemonetics Corporation | |
| 11 | 10887691304214 | BPFBLA | Leukotrap High Efficiency Leukocyte Reduction Filtration System for Red Blood Ce Leukotrap High Efficiency Leukocyte Reduction Filtration System for Red Blood Cells with BPF4 Filter | CAK | Microfilter, blood transfusion | 2 | Haemonetics Leukotrap SC RC | |
| 12 | 10887691000581 | RCXL1K | RCXL1 High Efficiency Leukocyte Redution Filter with Attached Straight Administr RCXL1 High Efficiency Leukocyte Redution Filter with Attached Straight Administration Set for Single Unit Blood Transfusion | CAK | Microfilter, blood transfusion | 2 | RCXL1 | |
| 13 | 10812747016278 | 0265F-00 | CS5/5+ FASTPACK, 125ML 20µ RES | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER 5/5+ SYSTEM | |
| 14 | 10812747016261 | 0260F-00 | CS5/5+ FASTPACK,225ML, 20µ RES | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER 5/5+ SYSTEM | |
| 15 | 10812747015172 | 0291A-00 | CELL SAVER 5/5+ BOWL SET (70ML) | CAC | Apparatus, Autotransfusion | HAEMONETICS CELL SAVER 5/5+ SYSTEM | ||
| 16 | 10812747015165 | 0263A-00 | HIGH SPEED CELL SAVER5/5+BOWL SET | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER 5/5+ SYSTEM | |
| 17 | 10812747012492 | 09082-00 | TPE PROTOCOL/MANUAL,LN09082-00 | GKT | Separator, automated, blood cell, diagnostic | 2 | MCS+ | |
| 18 | 10812747012485 | 09081-00 | SDP/PLP PROT MANUL,LN 09081-00 | GKT | Separator, automated, blood cell, diagnostic | 2 | MCS+ | |
| 19 | 10812747011761 | 00620-CP | PLS Harness Set | GKT | Separator, automated, blood cell, diagnostic | 2 | Haemonetics® PCS®2 & NexSys PCS™ Systems | |
| 20 | 10812747011754 | 00620-00 | PLS Harness Set | GKT | Separator, automated, blood cell, diagnostic | 2 | Haemonetics® PCS®2 & NexSys PCS™ Systems | |
| 21 | 10812747011730 | 00695-00 | PLS Saline Adaptor | GKT | Separator, automated, blood cell, diagnostic | 2 | Haemonetics® PCS®2 & NexSys PCS™ Systems | |
| 22 | 30812747019228 | 0697S-00 | Persona™ Plasma Pooling Bottles | KSR | CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS | 2 | Haemonetics® NexSys PCS® System | |
| 23 | 30812747016616 | CSE-E-US | CELL SAVER ELITE | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER ELITE SYSTEM | |
| 24 | 00812747010187 | 4.x.x | NexLynk DMS version 4.x.x | MMH | Blood Establishment Computer Software and Accessories | 2 | NexLynk DMS | |
| 25 | 00812747010149 | 3.x.x | ElDorado Donor version 3.x.x | MMH | SOFTWARE, BLOOD BANK, STAND ALONE PRODUCTS | 2 | ElDorado Donor | |
| 26 | 00812747010132 | 2.x.x | ElDorado Donor 2.x.x | MMH | SOFTWARE, BLOOD BANK, STAND ALONE PRODUCTS | 2 | ElDorado Donor | |
| 27 | 20812747016220 | 00401-00 | EXTENSION LINES | FRN | Pump, Infusion | HAEMONETICS R.I.S. SYSTEM | ||
| 28 | 10812747016636 | CSE-FP-225F | CS ELITE FASTPACK, 225ML, 20µ | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER ELITE SYSTEM | |
| 29 | 10812747016582 | CSE-FP-225V | CS ELITE FASTPACK,225ML,150µ | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER ELITE SYSTEM | |
| 30 | 10812747016575 | CSE-FP-125V | CS ELITE FASTPACK,125ML,150µ | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER ELITE SYSTEM | |
| 31 | 10812747016568 | CSE-B-1000 | WASTE BAG, 10L | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER ELITE SYSTEM | |
| 32 | 10812747016551 | CSE-SQ-1000 | SEQUESTRATION KIT | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER ELITE SYSTEM | |
| 33 | 10812747016544 | CSE-P-225 | CS ELITE PROCESSING KIT (225ML) | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER ELITE SYSTEM | |
| 34 | 10812747016537 | CSE-P-125 | CS ELITE PROCESSING KIT (125ML) | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER ELITE SYSTEM | |
| 35 | 10812747016520 | CSE-P-70 | CS ELITE PROCESSING KIT (70ML) | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER ELITE SYSTEM | |
| 36 | 30812747017910 | OPA-E-US | ORTHOPAT ADVANCE, LN OPA-E-US | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS ORTHOPAT ADVANCE SYSTEM | |
| 37 | 30812747016814 | 02005-110-EP | CS5+,110V ENG, LN02005-110-EP | CAC | Apparatus, Autotransfusion | 2 | HAEMONETICS CELL SAVER 5+ SYSTEM | |
| 38 | 00812747010200 | 3.x.x | Donor Doc version 3.x.x | MMH | Blood Establishment Computer Software and Accessories | 2 | Donor Doc | |
| 39 | 00812747010194 | 3.x.x | Symphony version 3.x.x | MMH | Blood Establishment Computer Software and Accessories | 2 | Symphony | |
| 40 | 00812747010064 | 1.x.x | CDCS version 1.x.x | MMH | Blood Establishment Computer Software and Accessories | 2 | CDCS (Cross Donation Check System) | |
| 41 | 30812747012878 | 09000-220-EW | MCS+, 220V, LN09000-220-EW-RU | GKT | Separator, automated, blood cell, diagnostic | 2 | HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM | |
| 42 | 30812747012854 | 09000-220-E | MCS+, 220V ENGL, LN 09000-220-E | GKT | Separator, automated, blood cell, diagnostic | 2 | HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM | |
| 43 | 30812747012816 | 09000-110-E | MCS+ ,110V ENGL, LN 09000-110-E | GKT | Separator, automated, blood cell, diagnostic | 2 | HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM | |
| 44 | 20887691308745 | 430-40 | Leukocyte Reduction Filter System for Red Blood Cells with BPF4 High Efficiency Leukocyte Reduction Filter System for Red Blood Cells with BPF4 High Efficiency Filter, 16-Segment Tubing, Storage Bag and Sample Pouch | CAK | Microfilter, blood transfusion | 2 | Leukocyte SC RC | |
| 45 | 10887691001243 | SB1E | LipiGuard SB Reinfusion Filter for Salvaged Blood | CAK | Microfilter, blood transfusion | 2 | LipiGuard SB | |
| 46 | 10887691000550 | PXL8Y | PXL 8 High Efficiency Leukocyte Reduction Filter for Platelets with Attached Y-T PXL 8 High Efficiency Leukocyte Reduction Filter for Platelets with Attached Y-Type Administration Set | CAK | Microfilter, blood transfusion | 2 | PXL 8 | |
| 47 | 10887691000536 | PXL8C | PXL 8 High Efficiency Leukocyte Reduction Filter for Platelets with Attached Extension Set | CAK | Microfilter, blood transfusion | 2 | PXL 8 | |
| 48 | 10887691000505 | PXL12K | PXL 12 High Efficiency Leukocyte Reduction Filter with Attached Straight Adminis PXL 12 High Efficiency Leukocyte Reduction Filter with Attached Straight Administration Set | CAK | Microfilter, blood transfusion | 2 | PXL 12 High Efficiency Leukocyte Reduction Filter | |
| 49 | 10812747018074 | 07-016 | PLATELETMAPPING ASSAY AA | JOZ | SYSTEM, AUTOMATED PLATELET AGGREGATION | 2 | TEG HEMOSTASIS SYSTEM | |
| 50 | 10812747018067 | 07-015 | PLATELETMAPPING ASSAY ADP | JOZ | SYSTEM, AUTOMATED PLATELET AGGREGATION | 2 | TEG HEMOSTASIS 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 |