No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 08426951346462 | 0003310300 | 00003310300 | Avox-4 CO-Oximeter Control, Level 3 | JJY | Multi-analyte controls, all kinds (assayed) | Avox-4 CO-Oximeter Control - L3 | |
2 | 08426951298778 | 00009800015 | 00009800015 | 1. HemosIL Acustar ß2GP1-Domain1 Reagent Cartridge (Cat. No. 000098000162. 1 Re 1. HemosIL Acustar ß2GP1-Domain1 Reagent Cartridge (Cat. No. 000098000162. 1 Resuspension buffer (Cat. No. 00009800019) 3. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 1 (Cat. No. 00009800017):4. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 2 (Cat. 00009800018): | MSV | System,test,antibodies,b2 - glycoprotein i (b2 - gpi) | 2 | HemosIL AcuStar Anti-B2GPI Domain 1 |
3 | 08426951293742 | 00044000115 | 00044000115 | GEM ChemSTAT CVP 1, 10 ampoules x 1.8 mL | JJY | Multi-Analyte Controls, All Kinds (Assayed) | GEM ChemSTAT CVP 1 | |
4 | 08426950716419 | 0005312 | 0005312 | Barcode wand | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | Barcode wand |
5 | 08426950497974 | 00000280010 | 00000280010 | ACL TOP 700 | GKP | INSTRUMENT, COAGULATION, AUTOMATED | 2 | ACL TOP 700 |
6 | 08426951027477 | 00055415004XC | 00055415004XC | GEM 5000 BG COOX 150 Test PAK 31 DAY (pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, HHb, GEM 5000 BG COOX 150 Test PAK 31 DAY (pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge) | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 5000 PAK BG COOX (150 TEST) |
7 | 08426951027453 | 00055445011XC | 00055445011XC | GEM 5000 BG ISE COOX TBILI 450 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca GEM 5000 BG ISE COOX TBILI 450 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glu, Lac, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2, Tbili Cartridge) | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 5000 PAK BG ISE GL COOX TBILI (450 TEST) |
8 | 08426951027361 | 00055360009XC | 00055360009XC | GEM 5000 BG ISE COOX TBILI 600 Test PAK 21 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca+ GEM 5000 BG ISE COOX TBILI 600 Test PAK 21 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2, Tbili Cartridge) | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 5000 PAK BG ISE COOX TBILI (600 TEST) |
9 | 08426950927990 | 00000280010R | 00000280010R | ACL TOP 700 (Refurbished) | GKP | INSTRUMENT, COAGULATION, AUTOMATED | 2 | ACL TOP 700 |
10 | 08426950807803 | 00055445009 | 00055445009 | GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tBili, tHb, O2Hb, C GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 450 Test 31 Days | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 5000 PAK BG/ISE/COOX/TBILI 450 TEST |
11 | 08426950807797 | 00055445008 | 00055445008 | GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, Me GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 450 Test 31 Days | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 5000 PAK BG/ISE/COOX 450 TEST |
12 | 08426950807766 | 00055430011 | 00055430011 | GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, t GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 300 Test 31 Days | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 300 TEST |
13 | 08426950807728 | 00055430005 | 00055430005 | GEM Premier 5000 PAK pH, pCO2, pO2, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 GEM Premier 5000 PAK pH, pCO2, pO2, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 300 Test 31 Days | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 5000 PAK BG/COOX/TBILI 300 TEST |
14 | 08426950807643 | 00055407511 | 00055407511 | GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, t GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 75 Test 31 Days | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 75 TEST |
15 | 08426950784050 | 00000280035 | 00000280035 | ACL TOP 750 LAS | GKP | INSTRUMENT, COAGULATION, AUTOMATED | 2 | ACL TOP 750 LAS |
16 | 08426950632870 | 00020301300 | 00020301300 | HemosIL ReadiPlasTin (10 mL) | GJS | TEST, TIME, PROTHROMBIN | 2 | HemosIL ReadiPlasTin (10 mL) |
17 | 08426950580690 | 00020012800 | 00020012800 | HemosIL Factor VIII Deficient Plasma | GJT | PLASMA, COAGULATION FACTOR DEFICIENT | HemosIL Factor VIII Deficient Plasma | |
18 | 08426950574255 | 00097579000 | 00097579000 | HemosIL Chromogenic Optic test 160umol L | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 2 | Chromogenic Optic 160 umol L |
19 | 08426950573500 | 00020301800 | 00020301800 | HemosIL Q.F.A. Thrombin (Bovine) - 2 mL | GIS | TEST, FIBRINOGEN | HemosIL Q.F.A. Thrombin (Bovine) - 2 mL | |
20 | 08426950566526 | 00020302000 | 00020302000 | HemosIL Protein S Activity | GGP | TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY | 2 | HemosIL Protein S Activity |
21 | 08426950554820 | 00027360008 | 00027360008 | GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, O2Hb, COHb, HHb, M GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 600 Test 21DAY | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM 4000 PAK BG ISE COOX 600 TEST 21 DAY |
22 | 08426950554813 | 00027360004 | 00027360004 | GEM Premier 4000 pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge GEM Premier 4000 pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 600 Test 21DAY | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM 4000 PAK BG COOX 600 TEST 21 DAY |
23 | 08426950554707 | 00027407509 | 00027407509 | GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tBili, tHb, O2Hb, COHb, GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 75 Test 30DAY | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM 4000 PAK BG ISE COOX BILI 75 TEST 30 DAY |
24 | 08426950543589 | 00027430008 | 00027430008 | GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, O2Hb, COHb, HHb, M GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 300 Test 30DAY | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM 4000 PAK BG ISE COOX 300 TEST 30 DAY |
25 | 08426950513278 | 00027415004 | 00027415004 | GEM Premier 4000 pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge GEM Premier 4000 pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 150 Test 30DAY | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM 4000 PAK BG COOX 150 TEST 30 DAY |
26 | 08426950511694 | 00026360089 | 00026360089 | GEM Premier 3500 3000 iQM 2WK BG LYTES GL (600 TEST) | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 3500 3000 iQM BG LYTES GL (600 TEST) |
27 | 08426950511656 | 00026345084 | 00026345084 | GEM Premier 3500 3000 iQM 3WK BG HCT (450 TEST) | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 3500 3000 iQM BG HCT (450 TEST) |
28 | 08426950497035 | 0009802200 | 0009802200 | HemosIL AcuStar System Rinse | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 2 | HemosIL AcuStar System Rinse |
29 | 08426950497004 | 0009802108 | 0009802108 | HemosIL AcuStar Anti-Cardiolipin IgM Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | HemosIL AcuStar Anti-Cardiolipin IgM Controls |
30 | 08426950496984 | 0009802016 | 0009802016 | HemosIL AcuStar Anti-B2 Glycoprotein-I IgM | MSV | System,test,antibodies,b2 - glycoprotein i (b2 - gpi) | 2 | HemosIL AcuStar Anti-B2 Glycoprotein-I IgM |
31 | 08426950472490 | 00020300200 | 00020300200 | HemosIL LMW Heparin Controls | KFF | ASSAY, HEPARIN | 2 | HemosIL LMW Heparin Controls |
32 | 08426950453031 | 00020007900 | 00020007900 | HemosIL Homocysteine Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | HemosIL Homocysteine Controls |
33 | 08426950453154 | 00003315250 | 00003315250 | Multi-4 CO-Oximeter Control, Level 1 | JJY | Multi-analyte controls, all kinds (assayed) | Multi-4 CO-Oximeter Control, Level 1 | |
34 | 08426950446217 | 00024360084 | 00024360084 | GEM Premier 3000 iQM 2WK - BG HCT - 600 Tests | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 3000 iQM - BG HCT - 600 Tests |
35 | 08426950446194 | 00027430004 | 00027430004 | GEM Premier 4000 pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge GEM Premier 4000 pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 300 Test 30DAY | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM 4000 PAK BG COOX 300 TEST 30 DAY |
36 | 08426950088554 | 06260032000 | 06260032000 | GEM Test Citrate PT Cartridges | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | GEM Test Citrate PT Cartridges | |
37 | 08426950088189 | 00024407584 | 00024407584 | GEM Premier 3000 iQM 4WK - BG HCT - 75 Tests | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 3000 iQM - BG HCT - 75 Tests |
38 | 08426950088004 | 00024307589 | 00024307589 | GEM Premier 3000 iQM 3WK - BG HCT ELECT. GL - 75 Tests | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 3000 iQM - BG HCT ELECT. GL - 75 Tests |
39 | 08426950087960 | 00024307584 | 00024307584 | GEM Premier 3000 iQM 3WK - BG HCT - 75 Tests | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 3000 iQM - BG HCT - 75 Tests |
40 | 08426950082538 | 00024345004 | 00024345004 | GEM Premier 3000 3WK - BG HCT - 450 Tests | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 3000 - BG HCT - 450 Tests |
41 | 08426950082491 | 00024315009 | 00024315009 | GEM Premier 3000 3WK - BG HCT ELECT. GL - 150 Tests | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 3000 - BG HCT ELECT. GL - 150 Tests |
42 | 08426950082484 | 00024315007 | 00024315007 | GEM Premier 3000 3WK - BG HCT ELECT. - 150 Tests | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 3000 - BG HCT ELECT. - 150 Tests |
43 | 08426950082453 | 00024360087 | 00024360087 | GEM Premier 3000 iQM 2WK - BG HCT ELECT. - 600 Tests | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 3000 iQM - BG HCT ELECT. - 600 Tests |
44 | 08426950082361 | 00024315084 | 00024315084 | GEM Premier 3000 iQM 3WK - BG HCT - 150 Tests | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 3000 iQM - BG HCT - 150 Tests |
45 | 08426950075899 | 00029400100 | 00029400100 | Cuvettes (2400 cuvettes) | GKP | INSTRUMENT, COAGULATION, AUTOMATED | Cuvettes (2400 cuvettes) | |
46 | 08426950071068 | 00020003110 | 00020003110 | HemosIL Normal Control ASSAYED | GGN | PLASMA, COAGULATION CONTROL | HemosIL Normal Control ASSAYED | |
47 | 08426950070320 | 00020002700 | 00020002700 | HemosIL Free Protein S | GGP | TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY | 2 | HemosIL Free Protein S |
48 | 08426950010906 | 00003510000 | 00003510000 | Urine Standard, 100 Na 100K | JJO | FLAME EMISSION PHOTOMETER FOR CLINICAL USE | 1 | Urine Standard, 100 Na 100K |
49 | 08426951391615 | 0020500300 | 00020500300 | HemosIL D-Dimer HS 500 (XL) | DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 2 | HemosIL D-Dimer HS 500 |
50 | 08426951346455 | 0003310200 | 00003310200 | Avox-4 CO-Oximeter Control, Level 2 | JJY | Multi-analyte controls, all kinds (assayed) | Avox-4 CO-Oximeter Control - L2 |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | EABA40000411 | 400-0041 | 400-0041 | The Piccolo® AmLyte 13 , used with the Piccolo Xpress® chemistry analyzer, is in The Piccolo® AmLyte 13 , used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, amylase, aspartate aminotransferase (AST), calcium, c-reactive protein (CRP), creatine kinase, creatinine, glucose, potassium, sodium, total bilirubin and blood urea nitrogen (BUN) in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement. | Piccolo AmLyte 13 | ABAXIS, INC. |
2 | EABA40000371 | 400-0037 | 400-0037 | The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemist The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, lactate, magnesium, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood or lithium heparinized plasma in a clinical laboratory setting or point-of-care location. | Piccolo MetLac 12 Panel | ABAXIS, INC. |
3 | EABA40000341 | 400-0034 | 400-0034 | The Piccolo® MetLyte Plus CRP reagent disc, used with the Piccolo Xpress® chemis The Piccolo® MetLyte Plus CRP reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of c-reactive protein (CRP), chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement. | Piccolo MetLyte Plus CRP | ABAXIS, INC. |
4 | EABA40000311 | 400-0031 | 400-0031 | The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry a The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry analyzer or Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of calcium, chloride, creatinine, glucose, lactate dehydrogenase, magnesium, potassium, sodium, total carbon dioxide, and blood urea nitrogen in a clinical laboratory setting or point-of-care location. This disc is for testing heparinized plasma and serum, only. | Piccolo Basic Metabolic Panel Plus | ABAXIS, INC. |
5 | EABA40000281 | 400-0028 | 400-0028 | The Piccolo® Comprehensive Metabolic Panel, used with the Piccolo® blood chemist The Piccolo® Comprehensive Metabolic Panel, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo Comprehensive Metabolic Panel | ABAXIS, INC. |
6 | EABA40000271 | 400-0027 | 400-0027 | The Piccolo® Renal Function Panel, used with the Piccolo® blood chemistry analyz The Piccolo® Renal Function Panel, used with the Piccolo® blood chemistry analyzer or the PiccoloXpress® chemistry analyzer is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo Renal Function Panel | ABAXIS, INC. |
7 | EABA40000241 | 400-0024 | 400-0024 | The Piccolo® Basic Metabolic Panel, used with the Piccolo blood chemistry analyz The Piccolo® Basic Metabolic Panel, used with the Piccolo blood chemistry analyzer or the PiccoloXpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of calcium, chloride, creatinine, glucose, potassium, sodium, total carbon dioxide, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo Basic Metabolic Panel | ABAXIS, INC. |
8 | EABA40000231 | 400-0023 | 400-0023 | The Piccolo® MetLyte 8 Panel, used with the Piccolo® blood chemistry analyzer or The Piccolo® MetLyte 8 Panel, used with the Piccolo® blood chemistry analyzer or the PiccoloXpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo MetLyte 8 Panel | ABAXIS, INC. |
9 | EABA40000221 | 400-0022 | 400-0022 | The Piccolo® Electrolyte Panel, used with the Piccolo® blood chemistry analyzer The Piccolo® Electrolyte Panel, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of chloride, potassium, sodium, and total carbon dioxide in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo Electrolyte Panel | ABAXIS, INC. |
10 | 00857969006037 | 903393 | 903393 | Electrode, Sodium | Alfa Wassermann | ALFA WASSERMANN, INC. |
11 | 00856522006118 | 049330 | 039903-10 | Combo Cartridge, 10pk. | CC Cartridge | LIFEHEALTH |
12 | 00856522006088 | 067660 | 065202 | GL Cartridge, 25 count | GL Cartridge | LIFEHEALTH |
13 | 00856522006033 | 054330 | 055704 | H4 Cartridge, 25 count | H4 Cartridge | LIFEHEALTH |
14 | 00856522006026 | 049220 | 048400 | H3 Cartridge, 25 count | H3 Cartridge | LIFEHEALTH |
15 | 00856522006002 | 049330 | 039903 | CC Cartridge, 25 count | CC Cartridge | LIFEHEALTH |
16 | 00853366007301 | E-300 | Na+ Electrode for Roche / Hitachi Chemistry Systems | PHOENIX DIAGNOSTICS, INC. | PHOENIX DIAGNOSTICS, INC. | |
17 | 00853366007226 | 16-206 | 16-206 | ISE Standard High for Roche / Hitachi Chemistry Systems | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. |
18 | 00853366007219 | 16-205 | 16-205 | ISE Standard Low for Roche / Hitachi Chemistry Systems | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. |
19 | 00853366007172 | 16-202 | 16-202 | ISE Internal Ref Sol for Roche / Hitachi 700 & 900 Series Chemistry Systems | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. |
20 | 00853366007141 | 16-200 | 16-200 | ISE Diluent for Roche / Hitachi 704, 902, and P800 Series Chemistry Systems | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. |
21 | 00853366007103 | E-900 | Na+ Electrode for Olympus AU Series Chemistry Systems | PHOENIX DIAGNOSTICS, INC. | PHOENIX DIAGNOSTICS, INC. | |
22 | 00853366007080 | 21-108 | ISE Na+ and K+ Selectivity Check Solutions for Olympus AU Series Chemistry Systems | PHOENIX DIAGNOSTICS, INC. | PHOENIX DIAGNOSTICS, INC. | |
23 | 00853366007073 | 21-107 | ISE Internal Reference Fill Solution for Olympus AU Series Chemistry Systems | PHOENIX DIAGNOSTICS, INC. | PHOENIX DIAGNOSTICS, INC. | |
24 | 00853366007059 | 21-105 | 21-105 | ISE High Serum Standard for Olympus AU Series Chemistry Systems | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. |
25 | 00853366007035 | 21-103 | 21-103 | ISE Reference Solution for Olympus AU Series Chemistry Systems | Phoenix Diagnostics, Inc. | PHOENIX DIAGNOSTICS, INC. |
26 | 00851445007259 | GEN-ISE REFERENCE | GEN-ISE REFERENCE | 10/17/2022 | GENCHEM™ ISE Electrolyte Reference | GENCHEM INC |
27 | 00851445007242 | GEN-ISE BUFFER | GEN-ISE BUFFER | 10/17/2022 | GENCHEM™ ISE Electrolyte Buffer | GENCHEM INC |
28 | 00850229007324 | 3910 | SelectaLyte (Sodium Electrode) | AWARENESS TECHNOLOGY, INCORPORATED | ||
29 | 00842768030413 | 10484429 | K800A | V-LYTE Integrated Multisensor | Dimension Vista® V-LYTE® Integrated Multisensor Na+ / K+ / Cl- | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
30 | 00842768014307 | 10445051 | S630 | Flush Solution, 3x1000mL | Dimension® QuikLYTE® Multisensor Flush Solution | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
31 | 00842768014291 | 10445058 | S600 | QuikLYTE® Integrated Multisensor | Dimension® QuikLYTE® Multisensor Na+/K+/Cl- | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
32 | 00842768014024 | 10444872 | S640 | Quiklyte Diluent Check, 60mL | Dimension® QuikLYTE® Integrated Multisensor Diluent Check | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
33 | 00842768014017 | 10444874 | S635 | Sample Diluent, 6x500mL | Dimension® QuikLYTE® Integrated Multisensor Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
34 | 00817302023220 | DT88811 | DT88811 | Carolina Liquid Chemistries Corp. ISE Reference Solution DT88811 | CAROLINA LIQUID CHEMISTRIES CORPORATION | |
35 | 00817302023213 | DT88820 | DT88811 | Carolina Liquid Chemistries Corp. ISE Internal Standard Solution DT88820 | CAROLINA LIQUID CHEMISTRIES CORPORATION | |
36 | 00817302023206 | DT88810 | DT88810 | Carolina Liquid Chemistries Corp. ISE Diluent DT88810 | CAROLINA LIQUID CHEMISTRIES CORPORATION | |
37 | 00817302023152 | CLC720 | CLC720 | CLC720 Chemistry Analyzer w/ISE | CLC720 Chemistry Analyzer w/ISE | CAROLINA LIQUID CHEMISTRIES CORPORATION |
38 | 00817302023145 | CLC720i | CLC720i | CLC720i Chemistry Analyzer w/ISE | CLC720i Chemistry Analyzer w/ISE | CAROLINA LIQUID CHEMISTRIES CORPORATION |
39 | 00817302023121 | 6410-ISEMod | 6410-ISEMod | CLC6410 Clinical Chemistry Analyzer with ISE | CLC6410 Chemistry Analyzer with ISE Module | CAROLINA LIQUID CHEMISTRIES CORPORATION |
40 | 00817302023114 | CLC-ISE | CLC-ISE | CLC1600 Clinical Chemistry Anallyzer with ISE | CLC1600 Chemistry Analyzer with ISE Module | CAROLINA LIQUID CHEMISTRIES CORPORATION |
41 | 00817302023107 | CLC-ISE | CLC-ISE | CLC800 Clinical Chemistry Anallyzer with ISE | CLC800 Chemistry Analyzer with ISE Module | CAROLINA LIQUID CHEMISTRIES CORPORATION |
42 | 00817302020670 | 88811 | 88811 | ISE (Electrolytes) Reference - CX3 Reagent 1 x 2000 mL | ISE ELECTROLYTE REFERENCE 88811 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
43 | 00817302020663 | 88810 | 88810 | ISE (Electrolytes) Buffer - CX3 Reagent 1 x 2000 mL | ISE ELECTROLYTE BUFFEER REAGENT KIT 88810 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
44 | 00811727014757 | HI790-REF | HI790-REF | For the quantitative determination of sodium, potassium, and chloride in serum. For the quantitative determination of sodium, potassium, and chloride in serum. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison’s disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. 6 x 2L | Pointe Scientific, Inc. ISE Internal Reference | POINTE SCIENTIFIC, INC. |
45 | 00811727012838 | HI990-REF | HI990-REF | ISE Internal Reference, for the quantitative determination of sodium, potassium, ISE Internal Reference, for the quantitative determination of sodium, potassium, and chloride in serum. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison’s disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Size: 5 x 600mL | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
46 | 00811727012722 | HI790-DIL | HI790-DIL | ISE Diluent, for the quantitative determination of sodium, potassium, and chlori ISE Diluent, for the quantitative determination of sodium, potassium, and chloride in serum. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison’s disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Size: 6 x 2L | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
47 | 00811727012432 | HI790-STH | HI790-STH | ISE Standard - High For the standardization of Sodium, Potassium and Chloride on ISE Standard - High For the standardization of Sodium, Potassium and Chloride on Ion Selective Electrodes.packaged at 10 x 2ml | Pointe Scientific, Inc | POINTE SCIENTIFIC, INC. |
48 | 00811727012425 | HI790-STL | HI790-STL | ISE Standard - Low For the standardization of Sodium, Potassium and Chloride on ISE Standard - Low For the standardization of Sodium, Potassium and Chloride on Ion Selective Electrodes.packaged at 10 x 2ml | Pointe Scientific | POINTE SCIENTIFIC, INC. |
49 | 00811727012401 | HI790-REF | HI790-REF | ISE Internal Reference Packaged at 6 x 2L | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
50 | 00809708116712 | HR-1R04-00-00 | HR-1R04-00-00 | EPOC READER, REFURBISHED, ROHS COMPLIANT | EPOCAL INC |