No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | M52592330 | 9233 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | Antiserum to Human Serum | ||
2 | M52590150 | 9015 | JZR | SUPPORT GELS | 1 | IEP Sponge Wicks (2/pkg) | ||
3 | M52558520 | 5852 | JOZ | SYSTEM, AUTOMATED PLATELET AGGREGATION | 2 | Plateletworks Combo-25 Kit | ||
4 | M5255526140 | 552614 | JHO | ELECTROPHORETIC SEPARATION, LIPOPROTEINS | 1 | SPIFE Vis Cholesterol Kit | ||
5 | M5255527030 | 552703 | CFF | Immunoelectrophoretic, Immunoglobulins, (G, A, M) | 2 | SPIFE Nexus IFE-6 Antisera Kit | ||
6 | M525AQCHP0 | AQC-HP | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 2 | Actalyke QC Kit - AQC-HP | ||
7 | M52552920 | 5292 | GGP | TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY | 2 | Protein S ELISA Kit | ||
8 | M52551280 | 5128 | GKA | ABNORMAL HEMOGLOBIN QUANTITATION | 2 | Hemolysate Reagent | ||
9 | M52590140 | 9014 | JJN | APPARATUS, ELECTROPHORESIS, FOR CLINICAL USE | 1 | Zip Zone Sponge Wicks | ||
10 | M5258JF520010 | 8JF52001 | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 2 | AggRAM Module (Domestic) | ||
11 | M52563000000 | 6300000 | LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 1 | Pipette, Variable Volume, 10-100 microliter | ||
12 | M52557700040 | 5770004 | JBP | ACTIVATED WHOLE BLOOD CLOTTING TIME | 2 | Actalyke XL, (CSA/CE), W/ Flash Memory | ||
13 | M52556510 | 5651 | KHE | REAGENT, OCCULT BLOOD | 2 | ColoCARE Office Pack | ||
14 | M52518200 | 1820 | CFF | Immunoelectrophoretic, Immunoglobulins, (G, A, M) | 2 | V8 WASTE DRAWER PACK | ||
15 | M52592500 | 9250 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | Antiserum to Human IgE | ||
16 | M5255526040 | 552604 | CIN | ELECTROPHORETIC SEPARATION, ALKALINE PHOSPHATASE ISOENZYMES | 2 | SPIFE Alkaline Phosphatase Gel Kit | ||
17 | M5255525970 | 552597 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | Blade Applicator Kit, 12 Sample | ||
18 | M5255524710 | 552471 | CEF | ELECTROPHORETIC, PROTEIN FRACTIONATION | 1 | SPIFE SPE HI RES 20 KIT | ||
19 | M5255524570 | 552457 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | SPIFE IgG IEF-10 Kit | ||
20 | M5255523040 | 552304 | CEF | ELECTROPHORETIC, PROTEIN FRACTIONATION | 1 | QUICKGEL SPE Gel Kit | ||
21 | M5255522890 | 552289 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | SPIFE ULTRA IFE-6 ANTISERA KIT | ||
22 | M5255521640 | 552164 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | SPIFE Ultra ImmunoFix-9 Antisera Kit | ||
23 | M5255521360 | 552136 | CEF | ELECTROPHORETIC, PROTEIN FRACTIONATION | 1 | QUICKGEL MODIFIED APPLICATOR BLADES AND DEEP WELL CUPS | ||
24 | M5255521250 | 552125 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | SPIFE Ultra ImmunoFix-15 Antisera Kit | ||
25 | M5255519410 | 551941 | JHO | ELECTROPHORETIC SEPARATION, LIPOPROTEINS | 1 | SPIFE Vis Cholesterol Reagent Kit | ||
26 | M52553680 | 5368 | GHR | REAGENT, PLATELET AGGREGATION | 2 | Collagen Reagent | ||
27 | M52553600 | 5360 | GGP | TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY | 2 | Rocket Stain | ||
28 | M52553410 | 5341 | JPD | HEMOGLOBIN A2 QUANTITATION | 2 | Beta-Thal HbA2 Quik Column Kit | ||
29 | M52553390 | 5339 | JCM | CONTROL, HEMOGLOBIN, ABNORMAL | 2 | Normal HbA2 Quik Column Control | ||
30 | M52551340 | 5134 | JJT | ENZYME CONTROLS (ASSAYED AND UNASSAYED) | 1 | CK/LD Isoenzyme Control (5 x 2 mL) | ||
31 | M52551270 | 5127 | GKA | ABNORMAL HEMOGLOBIN QUANTITATION | 2 | Hemolysate Reagent | ||
32 | M52551250 | 5125 | GKA | ABNORMAL HEMOGLOBIN QUANTITATION | 2 | Hemolysate Reagent | ||
33 | M52551020 | 5102 | CIN | ELECTROPHORETIC SEPARATION, ALKALINE PHOSPHATASE ISOENZYMES | 2 | Alkaline Phosphatase Indolyl Blue Reagent Kit | ||
34 | M52550930 | 5093 | LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 1 | Bufferizer | ||
35 | M52550900 | 5090 | LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 1 | Zip Zone Prep (1 x 60 mL) | ||
36 | M52550850 | 5085 | KHE | REAGENT, OCCULT BLOOD | 2 | ColoScreen-ES Take Home Pack | ||
37 | M52550830 | 5083 | KHE | REAGENT, OCCULT BLOOD | 2 | ColoScreen III 1000 Slide Pack | ||
38 | M52550820 | 5082 | KHE | REAGENT, OCCULT BLOOD | 2 | ColoScreen III Lab Pack | ||
39 | M52550050 | 5005 | KEM | AGENT, CLEARING | 1 | Clear Aid | ||
40 | M5255000910 | 500091 | KHE | REAGENT, OCCULT BLOOD | ColoScreen Developer | |||
41 | M52540840 | 4084 | JQW | STATION, PIPETTING AND DILUTING, FOR CLINICAL USE | 1 | Super Z Applicator (8-sample) | ||
42 | M52536150 | 3615 | GJG | Pipette, Quantitative, Hematology | 1 | H-Pette II (No Blade, Metal Canula) (1000 pieces) | ||
43 | M52536120 | 3612 | GJG | Pipette, Quantitative, Hematology | 1 | H-Pette with Blade (1000 pieces) | ||
44 | M52534270 | 3427 | LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 1 | SPIFE Urine/CSF Protein Accessories (50 templates plus blotters) | ||
45 | M52534260 | 3426 | JBD | SYSTEM, ANALYSIS, ELECTROPHORETIC HEMOGLOBIN | 2 | QuickGel Accessory Kit | ||
46 | M52534250 | 3425 | JJY | Multi-analyte controls, all kinds (assayed) | 1 | SPE Abnormal Control (10 x 2 mL) | ||
47 | M52530580 | 3058 | CIN | ELECTROPHORETIC SEPARATION, ALKALINE PHOSPHATASE ISOENZYMES | 2 | TITAN GEL Alkaline Phosphatase Kit | ||
48 | M52530410 | 3041 | CEF | ELECTROPHORETIC, PROTEIN FRACTIONATION | 1 | TITAN GEL Serum Protein Kit | ||
49 | M52530240 | 3024 | CEF | ELECTROPHORETIC, PROTEIN FRACTIONATION | 1 | Titan III Cellulose Acetate (94 x 76 mm) | ||
50 | M52523190 | 2319 | LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 1 | SPIFE 4000 Applicator Blades |
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. |