| 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 | 04260160470112 | ROTROL P | 503-25-US, 503-25 | ROTROL P is a quality control material for monitoring accuracy and precision of ROTROL P is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM® delta Thromboelastometry System. For in vitro diagnostic use only. | GGN,JPA | Plasma, Coagulation Control,System, Multipurpose For In Vitro Coagulation Studies | ROTEM® | |
| 8 | 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® | |
| 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® |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | M525AQCLP0 | AQC-LP | Actalyke QC Kit - AQC-LP | HELENA LABORATORIES CORPORATION | ||
| 2 | M525AQCHP0 | AQC-HP | Actalyke QC Kit - AQC-HP | HELENA LABORATORIES CORPORATION | ||
| 3 | M5258JF520010 | 8JF52001 | AggRAM Module (Domestic) | HELENA LABORATORIES CORPORATION | ||
| 4 | M52553750 | 5375 | Owren's Veronal Buffer | HELENA LABORATORIES CORPORATION | ||
| 5 | M52551860 | 5186 | NORM-TROL 1 Coagulation Control | HELENA LABORATORIES CORPORATION | ||
| 6 | M52551850 | 5185 | Coagulation S.A.R.P (Specialty Assayed Reference Plasma) | HELENA LABORATORIES CORPORATION | ||
| 7 | M52551830 | 5183 | AB-Trol 3 Coagulation Control | HELENA LABORATORIES CORPORATION | ||
| 8 | M52514870000 | 1487000 | AggRAM Module (110/220 V) | HELENA LABORATORIES CORPORATION | ||
| 9 | M52514840020 | 1484002 | AggRAM Analyzer, Windows 7 (110V/220V) | HELENA LABORATORIES CORPORATION | ||
| 10 | M52514840010 | 1484001 | AggRAM Analyzer (110V/220V) | HELENA LABORATORIES CORPORATION | ||
| 11 | M52514840000 | 1484000 | AggRAM Analyzer, Windows 2000 (110V/220V) | HELENA LABORATORIES CORPORATION | ||
| 12 | 08426951126538 | 0009800131 | 00009800131 | 1. Low HIT Control (Cat. No. 00009800132)2. High HIT Control (Cat. No. 00009800133): | HemosIL Acustar HIT Controls | INSTRUMENTATION LABORATORY COMPANY |
| 13 | 08426951024032 | 0022550030 | 00022550030 | HemosIL D-Dimer HS 500 Controls (Liquid) | HemosIL D-Dimer HS 500 Controls (Liquid) | INSTRUMENTATION LABORATORY COMPANY |
| 14 | 08426950975397 | 00020014700 | 00020014700 | HemosIL HIT-Ab(PF4-H) Controls | HemosIL HIT-Ab(PF4-H) Controls | INSTRUMENTATION LABORATORY COMPANY |
| 15 | 08426950965572 | 00000880311R | 00000880311R | ACL ELITE (Refurbished) | ACL ELITE | INSTRUMENTATION LABORATORY COMPANY |
| 16 | 08426950660675 | 00020014100 | 00020014100 | HemosIL Abnormal Control 3 | HemosIL Abnormal Control 3 | INSTRUMENTATION LABORATORY COMPANY |
| 17 | 08426950660668 | 00020014000 | 00020014000 | HemosIL Abnormal Control 2 | HemosIL Abnormal Control 2 | INSTRUMENTATION LABORATORY COMPANY |
| 18 | 08426950660651 | 00020013900 | 00020013900 | HemosIL Normal Control 1 | HemosIL Normal Control 1 | INSTRUMENTATION LABORATORY COMPANY |
| 19 | 08426950639725 | 3710-0344 | BIO-FLASH | BIO-FLASH | BIOKIT, S.A. | |
| 20 | 08426950585039 | 0009802204 | 0009802204 | HemosIL AcuStar Cleaning Solution | HemosIL AcuStar Cleaning Solution | INSTRUMENTATION LABORATORY COMPANY |
| 21 | 08426950584933 | 00020013100 | 00020013100 | HemosIL D-Dimer HS 500 Controls (Liquid) | HemosIL D-Dimer HS 500 Controls (Liquid) | INSTRUMENTATION LABORATORY COMPANY |
| 22 | 08426950574255 | 00097579000 | 00097579000 | HemosIL Chromogenic Optic test 160umol L | Chromogenic Optic 160 umol L | INSTRUMENTATION LABORATORY COMPANY |
| 23 | 08426950553502 | 00020302500 | 00020302500 | HemosIL Rinse Solution 2L (ACLFutura Advance) | HemosIL Rinse Solution (ACLFutura Advance) | INSTRUMENTATION LABORATORY COMPANY |
| 24 | 08426950515395 | 0020302400 | 00020302400 | HemosIL Rinse Solution 4L (ACL TOP Family) | HemosIL Rinse Solution (ACL TOP Family) | INSTRUMENTATION LABORATORY COMPANY |
| 25 | 08426950513735 | 00020012500 | 00020012500 | HemosIL LA Positive Control | HemosIL LA Positive Control | INSTRUMENTATION LABORATORY COMPANY |
| 26 | 08426950513728 | 00020012600 | 00020012600 | HemosIL LA Negative Control | HemosIL LA Negative Control | INSTRUMENTATION LABORATORY COMPANY |
| 27 | 08426950498032 | 0009802100 | 0009802100 | HemosIL AcuStar D-Dimer Controls | HemosIL AcuStar D-Dimer Controls | INSTRUMENTATION LABORATORY COMPANY |
| 28 | 08426950498001 | 0009801000 | 0009801000 | ACL AcuStar | HemosIL AcuStar | INSTRUMENTATION LABORATORY COMPANY |
| 29 | 08426950497042 | 0009802201 | 0009802201 | HemosIL AcuStar Triggers | HemosIL AcuStar Triggers | INSTRUMENTATION LABORATORY COMPANY |
| 30 | 08426950497035 | 0009802200 | 0009802200 | HemosIL AcuStar System Rinse | HemosIL AcuStar System Rinse | INSTRUMENTATION LABORATORY COMPANY |
| 31 | 08426950485629 | 00020010500 | 00020010500 | HemosIL INR Validate | HemosIL INR Validate | INSTRUMENTATION LABORATORY COMPANY |
| 32 | 08426950484745 | 00020011500 | 00020011500 | HemosIL Factor V Deficient Plasma (10 X 1 mL) | HemosIL Factor V Deficient Plasma (10 X 1 mL) | INSTRUMENTATION LABORATORY COMPANY |
| 33 | 08426950482970 | 00020500200 | 00020500200 | HemosIL D-Dimer HS 500 Controls | HemosIL D-Dimer HS 500 Controls | INSTRUMENTATION LABORATORY COMPANY |
| 34 | 08426950453482 | 00001000311R | 00001000311R | ACL ELITE PRO (Refurbished) | ACL ELITE PRO | INSTRUMENTATION LABORATORY COMPANY |
| 35 | 08426950453062 | 00020011000 | 00020011000 | HemosIL Special Test Control Level 1 | HemosIL Special Test Control Level 1 | INSTRUMENTATION LABORATORY COMPANY |
| 36 | 08426950453017 | 00000880311 | 00000880311 | ACL ELITE | ACL ELITE | INSTRUMENTATION LABORATORY COMPANY |
| 37 | 08426950452805 | 00009758080 | 00009758080 | COAGULOMETRIC OPTIC TEST, ACL FUTURA | Coagulation Optic (Advance) | INSTRUMENTATION LABORATORY COMPANY |
| 38 | 08426950452775 | 00009757950 | 00009757950 | HemosIL Chromogenic Optic Test Kit | Chromogenic Optic | INSTRUMENTATION LABORATORY COMPANY |
| 39 | 08426950452768 | 00009757980 | 00009757980 | KIT,CHROM OPTIC TEST 160MMOL L,FUTU ADVA | Chromogenic Optic (Advance) | INSTRUMENTATION LABORATORY COMPANY |
| 40 | 08426950452751 | 06260060600 | 06260060600 | GEM Check Coag Control-Normal for ACT-LR | GEM Check Coag Control-Normal for ACT-LR | INSTRUMENTATION LABORATORY COMPANY |
| 41 | 08426950452744 | 06260060500 | 06260060500 | GEM Check Coag Control-Normal for ACT | GEM Check Coag Control-Normal for ACT | INSTRUMENTATION LABORATORY COMPANY |
| 42 | 08426950452737 | 06260060400 | 06260060400 | GEM Check Coag Control-Normal for PT | GEM Check Coag Control-Normal for PT | INSTRUMENTATION LABORATORY COMPANY |
| 43 | 08426950452713 | 06260061400 | 06260061400 | GEM Check Coag Control-Abnormal for Citrate PT | GEM Check Coag Control-Abnormal for Citrate PT | INSTRUMENTATION LABORATORY COMPANY |
| 44 | 08426950452706 | 06260061700 | 06260061700 | GEM Check Coag Control-Abnormal for PT | GEM Check Coag Control-Abnormal for PT | INSTRUMENTATION LABORATORY COMPANY |
| 45 | 08426950452690 | 06260061600 | 06260061600 | GEM Check Coag Control-Normal for APTT | GEM Check Coag Control-Normal for APTT | INSTRUMENTATION LABORATORY COMPANY |
| 46 | 08426950452683 | 06260061100 | 06260061100 | GEM Check Coag Control-Normal for Citrate PT | GEM Check Coag Control-Normal for Citrate PT | INSTRUMENTATION LABORATORY COMPANY |
| 47 | 08426950452034 | 00009758050 | 00009758050 | HemosIL Coagulation Optic Test | Coagulation Optic | INSTRUMENTATION LABORATORY COMPANY |
| 48 | 08426950451570 | 00001000311 | 00001000311 | ACL ELITE PRO | ACL ELITE PRO | INSTRUMENTATION LABORATORY COMPANY |
| 49 | 08426950442189 | 00020012000 | 00020012000 | HemosIL Special Test Control Level 2 | HemosIL Special Test Control Level 2 | INSTRUMENTATION LABORATORY COMPANY |
| 50 | 08426950088653 | 06260060300 | 06260060300 | GEM Check Coag Control-Abnormal for ACT | GEM Check Coag Control-Abnormal for ACT | INSTRUMENTATION LABORATORY COMPANY |