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 | 10711234103401 | 000GACT+ | 000GACT+ | GH100 ACT+ 45 cuvettes/box. | JBP | Activated Whole Blood Clotting Time | 2 | GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+) |
35 | 20711234308186 | TL5000I | TL5000I | Tenderlett Finger Incision Device 5000/box | FMK | Lancet, Blood | Tenderlett Finger Incision Device | |
36 | 20711234308162 | TL100I | TL100I | Tenderlett Finger Incision Device 100/box | FMK | Lancet, Blood | Tenderlett Finger Incision Device | |
37 | 20711234304157 | SU50I | SU50I | Surgicutt Bleeding Time Device 50/box | JCA | Device, Bleeding Time | Surgicutt Bleeding Time Device | |
38 | 10711234540121 | 000GCCM | 000GCCM | Centralized Configuration Manager Software | JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | Centralized Configuration Manager Software |
39 | 10711234500170 | 86000RF | 86000RF | VerifyNow System (Refurbished) | JOZ | System, Automated Platelet Aggregation | 2 | VerifyNow System |
40 | 10711234500163 | 86000D | 86000D | VerifyNow System (Demonstration) | JOZ | System, Automated Platelet Aggregation | 2 | VerifyNow System |
41 | 10711234500156 | 86000L | 86000L | VerifyNow System (Loaner) | JOZ | System, Automated Platelet Aggregation | 2 | VerifyNow System |
42 | 10711234500149 | 86003D | 86003D | VerifyNow System (Demonstration) | JOZ | System, Automated Platelet Aggregation | 2 | VerifyNow System |
43 | 10711234500132 | 86003L | 86003L | VerifyNow System (Loaner) | JOZ | System, Automated Platelet Aggregation | 2 | VerifyNow System |
44 | 10711234500118 | 86003 | 86003 | VerifyNow System (Serviced) | JOZ | System, Automated Platelet Aggregation | 2 | VerifyNow System |
45 | 10711234500095 | 85021 | 85021 | VerifyNow Printer Kit | JOZ | System, Automated Platelet Aggregation | 2 | VerifyNow System |
46 | 10711234500040 | 86000 | 86000 | VerifyNow System | JOZ | System, Automated Platelet Aggregation | 2 | VerifyNow System |
47 | 10711234170366 | 000DCGLR-1 | 000DCGLR-1 | directCHECK GH100 ACTLRL1 15/box. | GGN | Plasma, Coagulation Control | 2 | directCHECK ACT-LR Whole Blood Controls, Level 1 |
48 | 10711234170342 | 000DCGACT-1 | 000DCGACT-1 | directCHECK GH100 ACT+L1 15/box | GGN | Plasma, Coagulation Control | 2 | directCHECK ACT+ Whole Blood Control Level 1 |
49 | 10711234150122 | 70068 | 70068 | VerifyNow System Electronic Quality Control Device | JOZ | System, Automated Platelet Aggregation | 2 | VerifyNow System |
50 | 10711234150115 | 85062 | 85062 | VerifyNow System Preventative Maintenance Kit | JOZ | System, Automated Platelet Aggregation | 2 | VerifyNow System |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 07640175460020 | 502-22 | 502-22 | Control plasma for assays aimed to determine the functional phenotype for activa Control plasma for assays aimed to determine the functional phenotype for activated protein C resistance caused by the Factor V Leiden mutation (FV:Q506). | Pefakit | DSM NUTRITIONAL PRODUCTS AG ZWEIGNIEDERLASSUNG PENTAPHARM |
2 | 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 |
3 | 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 |
4 | 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 |
5 | 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 |
6 | 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 |
7 | 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 |
8 | 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 |
9 | 03663537043550 | 224201 | 224201 | BIOPHEN LMWH Control C4 | HYPHEN BIOMED | |
10 | 03663537043512 | 224401 | 224401 | BIOPHEN LMWH CONTROL LOW CII | HYPHEN BIOMED | |
11 | 03663537043505 | 224301 | 224301 | BIOPHEN LMWH CONTROL LOW CI | HYPHEN BIOMED | |
12 | 03663537042904 | 224101 | 224101 | BIOPHEN UFH Control C1 | HYPHEN BIOMED | |
13 | 03663537008368 | 223701 | 223701 | BIOPHEN LMWH Control Low | HYPHEN BIOMED | |
14 | 03663537008320 | 223405 | 223405 | BIOPHEN™ V-L Control Plasma | HYPHEN BIOMED | |
15 | 03663537008313 | 223301 | 223301 | BIOPHEN ABNORMAL CONTROL PLASMA | HYPHEN BIOMED | |
16 | 03663537008306 | 223201 | 223201 | BIOPHEN NORMAL CONTROL PLASMA | HYPHEN BIOMED | |
17 | 03663537008290 | 223101 | 223101 | BIOPHEN UFH Control Plasma | HYPHEN BIOMED | |
18 | 03663537008283 | 223001 | 223001 | BIOPHEN LMWH Control Plasma | HYPHEN BIOMED | |
19 | 03663537008276 | 222301 | 222301 | BIOPHEN UFH Calibrator | HYPHEN BIOMED | |
20 | 03663537008252 | 222101 | 222101 | BIOPHEN PLASMA CALIBRATOR | HYPHEN BIOMED | |
21 | 03663537008245 | 222001 | 222001 | BIOPHEN Heparin Calibrator | HYPHEN BIOMED | |
22 | 03663537007996 | 223901 | 223901 | BIOPHEN UFH CONTROL C2 | HYPHEN BIOMED | |
23 | 03663537007989 | 223801 | 223801 | BIOPHEN LMWH Control C3 | HYPHEN BIOMED | |
24 | 03607450006865 | 00686 | STA® - Quality HBPM/LMWH | DIAGNOSTICA STAGO | ||
25 | 03607450006780 | 00678 | STA® - System Control N + P | DIAGNOSTICA STAGO | ||
26 | 03607450006773 | 00677 | STA® - Coag Control (N + ABN) PLUS | DIAGNOSTICA STAGO | ||
27 | 03607450006766 | 00676 | STA® - Coag Control N + ABN | DIAGNOSTICA STAGO | ||
28 | 03607450005264 | 00526 | STA® - Liatest® Control N + P | DIAGNOSTICA STAGO | ||
29 | 03607450003819 | 00381 | STA® - Quality HNF/UFH | DIAGNOSTICA STAGO | ||
30 | 03607450002010 | 00201 | STA® - Control LA 1 + 2 | DIAGNOSTICA STAGO | ||
31 | 00885074184937 | 550-11 | CALCIUM CHLORIDE 5 ML | NA | MEDTRONIC, INC. | |
32 | 00859110005111 | 903se | 903se | Validate Heparin is intended for the quantitative determination of Calibration V Validate Heparin is intended for the quantitative determination of Calibration Verification/Linearity of the heparin anti-Xa activity on automated instruments | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
33 | 00859110005104 | 903st | 903st | Validate Heparin is intended for the quantitative determination of Calibration V Validate Heparin is intended for the quantitative determination of Calibration Verification/Linearity of the heparin anti-Xa activityon automated instruments | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
34 | 00859110005098 | 903il | 903il | Validate Heparin is intended for the quantitative determination of Calibration V Validate Heparin is intended for the quantitative determination of Calibration Verification/Linearity of the heparin anti-Xa activityon automated instruments | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
35 | 00859110005081 | 902se | 902se | Validate D-Dimer is intended for the quantitative determination of Calibration V Validate D-Dimer is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
36 | 00859110005074 | 902st | 902st | Validate D-Dimer is intended for the quantitative determination of Calibration V Validate D-Dimer is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
37 | 00859110005067 | 902il | 902il | Validate D-Dimer is intended for the quantitative determination of Calibration V Validate D-Dimer is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
38 | 00850201006208 | 840C | 840C | ACTICLOT Protein C Resistance control plasmas | BIOMEDICA ADI INC. | |
39 | 00847661004516 | 27102X | 27102X | Liquichek D-dimer Control MiniPak (A processed human plasma assayed D-dimer control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
40 | 00847661004509 | 27103 | 27103 | Liquichek D-dimer Control Level 3 (A processed human plasma assayed D-dimer control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
41 | 00847661004493 | 27102 | 27102 | Liquichek D-dimer Control Level 2 (A processed human plasma assayed D-dimer control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
42 | 00847661004486 | 27101 | 27101 | Liquichek D-dimer Control Level 1 (A processed human plasma assayed D-dimer control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
43 | 00847661004479 | 27100 | 27100 | Liquichek D-dimer Control Level Low (A processed human plasma assayed D-dimer control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
44 | 00847661001959 | 745X | 745X | Lyphochek Coagulation Control Level Trilevel MiniPak (A human plasma coagulatio Lyphochek Coagulation Control Level Trilevel MiniPak (A human plasma coagulation control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
45 | 00847661001898 | 598X | 598X | Lyphochek Hemostasis Control MiniPak (A human plasma hemostasis control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
46 | 00847661001041 | 599 | 599 | Lyphochek Hemostasis Control Level 3 (A human plasma hemostasis control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
47 | 00847661001034 | 598 | 598 | Lyphochek Hemostasis Control Level 2 (A human plasma hemostasis control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
48 | 00847661001027 | 597 | 597 | Lyphochek Hemostasis Control Level 1 (A human plasma hemostasis control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
49 | 00847661000792 | 746 | 746 | Lyphochek Coagulation Control Level 3 (A human plasma coagulation control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
50 | 00847661000785 | 745 | 745 | Lyphochek Coagulation Control Level 2 (A human plasma coagulation control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |