| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | B55880004261 | 800-0426 | 800-0426 | The Non-Activated Clotting Test Kit contains the necessary components for an in The Non-Activated Clotting Test Kit contains the necessary components for an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. It may be used with native whole blood, citrated whole blood, and plasma. The Non-Activated Kit may either be used as a non-activated clotting test or as a general use test with user provided activators. It is intended for customer designed hemostasis monitoring on the Sonoclot Analyzer. The Non-Activated cuvette allows for coagulation monitoring using tissue activation, thrombin activation, and other custom activators. Some of the applications for the Non-Activated test with the addition of customer determined reagents are monitoring of fibrin formation, fibrinolysis, hyperfibrinolysis and clot retraction. When used with the Sonoclot Analyzer System, the Non-Activated 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 24 lidded plastic cuvettes, 24 probes, and instructions for use. The cuvettes contain a magnetic stir bar. | JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | Sonoclot® NonActivated Kit |
| 2 | B55880004251 | 800-0425 | 800-0425 | The Non-Activated Clotting Test Kit contains the necessary components for an in The Non-Activated Clotting Test Kit contains the necessary components for an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. It may be used with native whole blood, citrated whole blood, and plasma. The Non-Activated Kit may either be used as a non-activated clotting test or as a general use test with user provided activators. It is intended for customer designed hemostasis monitoring on the Sonoclot Analyzer. The Non-Activated cuvette allows for coagulation monitoring using tissue activation, thrombin activation, and other custom activators. Some of the applications for the Non-Activated test with the addition of customer determined reagents are monitoring of fibrin formation, fibrinolysis, hyperfibrinolysis and clot retraction. When used with the Sonoclot Analyzer System, the Non-Activated 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 plastic cuvettes, 100 probes, and instructions for use. The cuvettes contain a magnetic stir bar. | JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | Sonoclot® NonActivated Kit |
| 3 | B55880004121 | 800-0412 | 800-0412 | The gbACT+ Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coag The gbACT+ Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The gbACT+ test is a glass bead activated whole blood clotting time test. It may also be used with citrated whole blood and plasma. Warning: The gbACT+ test is not intended for high dose heparin management during cardiopulmonary bypass surgery.The gbACT+ 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 at low to moderate heparin levels (0 to 2 units per ml), hypercoagulable and/or hypocoagulable screening, platelet function assessment, and hyperfibrinolysis screening.When used with the Sonoclot Analyzer System, the gbACT+ 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 pink plastic activation cuvettes, 100 probes, and instructions for use. The activation cuvettes contain a controlled amount of glass beads and a magnetic stir bar. | JBP | Activated Whole Blood Clotting Time | 2 | Sonoclot® gbACT+ Kit |
| 4 | B55880004011 | 800-0401 | 800-0401 | The kACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulat The kACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The kACT test is a kaolin activated whole blood clotting time test. It may also be used with citrated whole blood and plasma. The kACT Kit is intended for high dose heparin management with or without aprotinin. The kACT test provides quantitative Onset/ACT and Clot Rate results with the Sonoclot Analyzer. The kACT test is not intended for platelet function monitoring. Each kit contains 24 lidded blue plastic activation cuvettes, 24 probes, and instructions for use. The activation cuvettes contain a controlled amount of kaolin and a magnetic stir bar. | JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | Sonoclot® kACT Kit |
| 5 | B55880004001 | 800-0400 | 800-0400 | The kACT Kit is an in vitro diagnostic test for use with the Sonoclot Coagulatio The kACT Kit is an in vitro diagnostic test for use with the Sonoclot Coagulation & Platelet Function Analyzer System. The kACT test is a kaolin activated whole blood clotting time test. It may also be used with citrated whole blood and plasma.The kACT kit is intended for high dose heparin management with or without aprotinin. The kACT test provides quantitative Onset/ACT and Clot Rate results with the Sonoclot Analyzer. The kACT test is not intended for platelet function monitoring.Each kACT Kit contains 100 lidded blue plastic activation cuvettes, 100 probes, and instructions for use. The activation cuvettes contain a controlled amount of kaolin and a magnetic stir bar. | JPA | System, Multipurpose For In Vitro Coagulation Studies | Sonoclot® kACT Kit | |
| 6 | 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) | JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | Sonoclot® Reference Plasma Quality Control Kit |
| 7 | 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. | JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | Sonoclot® Reference Viscosity Oil Quality Control Kit |
| 8 | 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. | JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | Sonoclot® SonACT Kit |
| 9 | B55880004311 | 800-0431 | 800-0431 | 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 24 lidded colorless plastic activation cuvettes, 24 probes, and instructions for use. The activation cuvettes contain a controlled amount of celite and a magnetic stir bar. | JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | Sonoclot® SonACT Kit |
| 10 | B55880004421 | 800-0442 | 800-0442 | The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulat The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The aiACT test is an activated whole blood clotting time test which uses a blend of celite and clay for contact activation. It may also be used with citrated whole blood.The aiACT Kit is only intended for high dose (ACT greater or equal to 400 seconds, on Sonoclot Analyzer) heparin anticoagulation management as typically encountered during cardiopulmonary bypass surgery. The aiACT test provides ACT results that are substantially unaffected by aprotinin. When used with the Sonoclot Analyzer System, the aiACT test provides quantitative Onset/ACT and Clot Rate results. Do not use the aiACT test for platelet function assessment. Each kit contains 100 lidded yellow plastic activation cuvettes, 100 probes, and instructions for use. The activation cuvettes contain a controlled amount of contact activator and a magnetic stir bar. | JBP | Activated Whole Blood Clotting Time | 2 | Sonoclot® aiACT Kit |
| 11 | B55880004411 | 800-0441 | 800-0441 | The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulat The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The aiACT test is an activated whole blood clotting time test which uses a blend of celite and clay for contact activation. It may also be used with citrated whole blood.The aiACT Kit is only intended for high dose (ACT greater or equal to 400 seconds, on Sonoclot Analyzer) heparin anticoagulation management as typically encountered during cardiopulmonary bypass surgery. The aiACT test provides ACT results that are substantially unaffected by aprotinin. When used with the Sonoclot Analyzer System, the aiACT test provides quantitative Onset/ACT and Clot Rate results. Do not use the aiACT test for platelet function assessment. Each kit contains 24 lidded yellow plastic activation cuvettes, 24 probes, and instructions for use. The activation cuvettes contain a controlled amount of contact activator and a magnetic stir bar. | JBP | Activated Whole Blood Clotting Time | 2 | Sonoclot® aiACT Kit |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | B55880004421 | 800-0442 | 800-0442 | The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulat The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The aiACT test is an activated whole blood clotting time test which uses a blend of celite and clay for contact activation. It may also be used with citrated whole blood.The aiACT Kit is only intended for high dose (ACT greater or equal to 400 seconds, on Sonoclot Analyzer) heparin anticoagulation management as typically encountered during cardiopulmonary bypass surgery. The aiACT test provides ACT results that are substantially unaffected by aprotinin. When used with the Sonoclot Analyzer System, the aiACT test provides quantitative Onset/ACT and Clot Rate results. Do not use the aiACT test for platelet function assessment. Each kit contains 100 lidded yellow plastic activation cuvettes, 100 probes, and instructions for use. The activation cuvettes contain a controlled amount of contact activator and a magnetic stir bar. | Sonoclot® aiACT Kit | SIENCO, INC. |
| 2 | B55880004411 | 800-0441 | 800-0441 | The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulat The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The aiACT test is an activated whole blood clotting time test which uses a blend of celite and clay for contact activation. It may also be used with citrated whole blood.The aiACT Kit is only intended for high dose (ACT greater or equal to 400 seconds, on Sonoclot Analyzer) heparin anticoagulation management as typically encountered during cardiopulmonary bypass surgery. The aiACT test provides ACT results that are substantially unaffected by aprotinin. When used with the Sonoclot Analyzer System, the aiACT test provides quantitative Onset/ACT and Clot Rate results. Do not use the aiACT test for platelet function assessment. Each kit contains 24 lidded yellow plastic activation cuvettes, 24 probes, and instructions for use. The activation cuvettes contain a controlled amount of contact activator and a magnetic stir bar. | Sonoclot® aiACT Kit | SIENCO, INC. |
| 3 | B55880004121 | 800-0412 | 800-0412 | The gbACT+ Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coag The gbACT+ Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The gbACT+ test is a glass bead activated whole blood clotting time test. It may also be used with citrated whole blood and plasma. Warning: The gbACT+ test is not intended for high dose heparin management during cardiopulmonary bypass surgery.The gbACT+ 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 at low to moderate heparin levels (0 to 2 units per ml), hypercoagulable and/or hypocoagulable screening, platelet function assessment, and hyperfibrinolysis screening.When used with the Sonoclot Analyzer System, the gbACT+ 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 pink plastic activation cuvettes, 100 probes, and instructions for use. The activation cuvettes contain a controlled amount of glass beads and a magnetic stir bar. | Sonoclot® gbACT+ Kit | SIENCO, INC. |
| 4 | B55880004111 | 800-0411 | 800-0411 | The gbACT+ Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coag The gbACT+ Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The gbACT+ test is a glass bead activated whole blood clotting time test. It may also be used with citrated whole blood and plasma. Warning: The gbACT+ test is not intended for high dose heparin management during cardiopulmonary bypass surgery.The gbACT+ 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 at low to moderate heparin levels (0 to 2 units per ml), hypercoagulable and/or hypocoagulable screening, platelet function assessment, and hyperfibrinolysis screening.When used with the Sonoclot Analyzer System, the gbACT+ 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 24 lidded pink plastic activation cuvettes, 24 probes, and instructions for use. The activation cuvettes contain a controlled amount of glass beads and a magnetic stir bar. | Sonoclot® gbACT+ Kit | SIENCO, INC. |
| 5 | 20812747018088 | 07-032 | RAPIDTEG REAGENT | TEG5000 HEMOSTASIS SYSTEM | HAEMONETICS CORPORATION | |
| 6 | 20763000014869 | 550-12 | CONTROL 550-12 CLOTTRAC HTC 15BX | CLOTtrac™ | MEDTRONIC, INC. | |
| 7 | 20763000014852 | 550-10 | CONT 550-10 CLOTTRAC RACT ABN 11L 15BX | CLOTtrac™ | MEDTRONIC, INC. | |
| 8 | 20763000014845 | 550-09 | CONT 550-09 CLOTTRAC LR ABN BXD ASY 15BX | CLOTtrac™ | MEDTRONIC, INC. | |
| 9 | 20763000014838 | 550-08 | CONT 550-08 CLOTTRAC HR ABN BXD ASY 15BX | CLOTtrac™ | MEDTRONIC, INC. | |
| 10 | 20763000014821 | 550-07 | CONTROL 550-07 CLOTTRAC HR 11L 15BX | CLOTtrac™ | MEDTRONIC, INC. | |
| 11 | 20643169730155 | 304-20POR | CRTG 304-20POR PORC HDR 5L INT 9BX | N/A | MEDTRONIC, INC. | |
| 12 | 20643169713264 | 402-07 | CARTRIDGE 402-07 HR HTC BXD 11L 20BX | NA | MEDTRONIC, INC. | |
| 13 | 20643169577491 | 402-03 | CARTRIDGE 402-03 ACT HR 13 LAN | HR-ACT | MEDTRONIC, INC. | |
| 14 | 20643169577460 | 402-01 | CARTRIDGE 402-01 ACT LR 13 LAN | LR-ACT | MEDTRONIC, INC. | |
| 15 | 20613994923343 | 550-12 | BOXED 550-12 CLOTTRAC HTC CONTROL | CLOTtrac® | MEDTRONIC, INC. | |
| 16 | 20613994923275 | 304-20POR | CRTG 304-20POR PORC HDR 5L INT 9BX | NA | MEDTRONIC, INC. | |
| 17 | 20613994417293 | 402-03 | CARTRIDGE 402-03 ACT HR 13 LAN | HR-ACT | MEDTRONIC, INC. | |
| 18 | 10885074184927 | 550-10 | CONT 550-10 CLOTTRAC RACT ABN 11L 15BX | CLOTtrac® | MEDTRONIC, INC. | |
| 19 | 10885074184910 | 550-09 | CONT 550-09 CLOTTRAC LR ABN BXD ASY 15BX | CLOTtrac® | MEDTRONIC, INC. | |
| 20 | 10885074184880 | 550-08 | CONT 550-08 CLOTTRAC HR ABN BXD ASY 15BX | CLOTtrac® | MEDTRONIC, INC. | |
| 21 | 10885074184873 | 550-07 | CONTROL 550-07 CLOTTRAC HR 11L 15BX | CLOTtrac® | MEDTRONIC, INC. | |
| 22 | 10885074117314 | 402-07 | CARTRIDGE 402-07 HR HTC BXD 11L 20BX | HR HTC | MEDTRONIC, INC. | |
| 23 | 10711234103418 | 000GACT-LR | 000GACT-LR | GH100 ACT-LR 45 cuvettes/box | GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR) | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
| 24 | 10711234103401 | 000GACT+ | 000GACT+ | GH100 ACT+ 45 cuvettes/box. | GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+) | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
| 25 | 10711234103081 | JACT-LR | JACT-LR | ACT-Low Range Cuvettes - 45 cuvettes/box. | Hemochron Whole Blood Microcoagulation System | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
| 26 | 10711234103067 | JACT+ | JACT+ | ACT+ Cuvette - 45 cuvettes/box. | Hemochron Whole Blood Microcoagulation System | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
| 27 | 10711234101391 | HRFTK-ACT | HRFTK-ACT | Kaolin ACT Tubes - 95 tubes/box | Hemochron Whole Blood Coagulation System | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
| 28 | 10711234101384 | HRFTCA510 | HRFTCA510 | Celite ACT Tubes - 95 tubes/box | Hemochron Whole Blood Coagulation System | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
| 29 | 10711234101094 | P214 | P214 | ACT Tubes 95 tubes/box | Hemochron Whole Blood Coagulation System | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
| 30 | M525MAXACT0 | MAX-ACT | Actalyke MAX-ACT Tubes | HELENA LABORATORIES CORPORATION | ||
| 31 | M525KACT0 | K-ACT | K-ACT Tubes | HELENA LABORATORIES CORPORATION | ||
| 32 | M525GACT0 | G-ACT | G-ACT Tubes | HELENA LABORATORIES CORPORATION | ||
| 33 | M525CACT0 | C-ACT | C-ACT Tubes | HELENA LABORATORIES CORPORATION | ||
| 34 | M52557700040 | 5770004 | Actalyke XL, (CSA/CE), W/ Flash Memory | HELENA LABORATORIES CORPORATION | ||
| 35 | M52557700030 | 5770003 | Actalyke XL, (CSA/CE), New Display #2 (110V/220V) | HELENA LABORATORIES CORPORATION | ||
| 36 | M52557700020 | 5770002 | Actalyke XL, Dual Detection, (Display #2) "CE" (110V/220V) | HELENA LABORATORIES CORPORATION | ||
| 37 | M52557700010 | 5770001 | Actalyke XL, Dual Detection, (New Display) "CE" (110V/220V) | HELENA LABORATORIES CORPORATION | ||
| 38 | M52557550010 | 5755001 | Actalyke Mini II, w/o Printer & Battery, "CE 2009" (110V/220V) | HELENA LABORATORIES CORPORATION | ||
| 39 | M52557550000 | 5755000 | Actalyke Mini II, w/o Printer & Battery., "CE" (110V/220V) | HELENA LABORATORIES CORPORATION | ||
| 40 | M52557530010 | 5753001 | Actalyke Mini II, w/ Printer, w/o Battery, "CE 2009" (110V/220V) | HELENA LABORATORIES CORPORATION | ||
| 41 | M52557530000 | 5753000 | Actalyke Mini II, w/ Printer, w/o Battery, "CE" (110V/220V) | HELENA LABORATORIES CORPORATION | ||
| 42 | 10054749000156 | 03P87-25 | 03P87-25 | Kaolin ACT CARTRIDGE | i-STAT | ABBOTT POINT OF CARE INC. |
| 43 | 10054749000149 | 03P86-25 | 03P86-25 | Celite ACT CARTRIDGE | i-STAT | ABBOTT POINT OF CARE INC. |