| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00385480560375 | 1.75 | 56037 | StatStrip Docking Station Remanufactured 4 position 1.75 | CGA,CGL,KHP | GLUCOSE OXIDASE, GLUCOSE,ELECTRODE, ION BASED, ENZYMATIC, CREATININE,ACID, LACTI GLUCOSE OXIDASE, GLUCOSE,ELECTRODE, ION BASED, ENZYMATIC, CREATININE,ACID, LACTIC, ENZYMATIC METHOD | 1 | StatSensor/StatStrip |
| 2 | 00385480560368 | 1.75 | 56036 | StatStrip Docking Station Remanufactured 2 position 1.75 | CGL,KHP,CGA | ELECTRODE, ION BASED, ENZYMATIC, CREATININE,ACID, LACTIC, ENZYMATIC METHOD,GLUCO ELECTRODE, ION BASED, ENZYMATIC, CREATININE,ACID, LACTIC, ENZYMATIC METHOD,GLUCOSE OXIDASE, GLUCOSE | 1 | StatSensor/StatStrip |
| 3 | 00385480544221 | 1.0 | 54422 | StatStrip StatSensor Remanufactured Wireless Carrying Case for Meter and Supplies v1.0 | KHP,CGL,CGA | ACID, LACTIC, ENZYMATIC METHOD,ELECTRODE, ION BASED, ENZYMATIC, CREATININE,GLUCO ACID, LACTIC, ENZYMATIC METHOD,ELECTRODE, ION BASED, ENZYMATIC, CREATININE,GLUCOSE OXIDASE, GLUCOSE | 1 | StatSensor/StatStrip |
| 4 | 00385480544191 | 1.75 | 54419 | StatStrip StatSensor Remanufactured Wireless Carrying Case for Meter and Supplies | KHP,CGL,CGA | ACID, LACTIC, ENZYMATIC METHOD,ELECTRODE, ION BASED, ENZYMATIC, CREATININE,GLUCO ACID, LACTIC, ENZYMATIC METHOD,ELECTRODE, ION BASED, ENZYMATIC, CREATININE,GLUCOSE OXIDASE, GLUCOSE | 1 | StatSensor/StatStrip |
| 5 | 00385480534390 | 1.75 | 53439 | StatStrip StatSensor Wireless Carrying Case for Meter and Supplies | CGL,KHP,CGA | ELECTRODE, ION BASED, ENZYMATIC, CREATININE,ACID, LACTIC, ENZYMATIC METHOD,GLUCO ELECTRODE, ION BASED, ENZYMATIC, CREATININE,ACID, LACTIC, ENZYMATIC METHOD,GLUCOSE OXIDASE, GLUCOSE | 1 | StatSensor/StatStrip |
| 6 | 00385480534024 | 1.75 | 53402 | StatStrip StatSensor Docking Station | CGA,KHP,CGL | GLUCOSE OXIDASE, GLUCOSE,ACID, LACTIC, ENZYMATIC METHOD,ELECTRODE, ION BASED, EN GLUCOSE OXIDASE, GLUCOSE,ACID, LACTIC, ENZYMATIC METHOD,ELECTRODE, ION BASED, ENZYMATIC, CREATININE | 1 | StatSensor/StatStrip |
| 7 | 00385480534017 | 1.75 | 53401 | StatStrip StatSensor Docking Station | KHP,CGL,CGA | ACID, LACTIC, ENZYMATIC METHOD,ELECTRODE, ION BASED, ENZYMATIC, CREATININE,GLUCO ACID, LACTIC, ENZYMATIC METHOD,ELECTRODE, ION BASED, ENZYMATIC, CREATININE,GLUCOSE OXIDASE, GLUCOSE | 1 | StatSensor/StatStrip |
| 8 | 00385480534000 | 1.75 | 53400 | StatStrip StatSensor Docking Station | CGL,KHP,CGA | ELECTRODE, ION BASED, ENZYMATIC, CREATININE,ACID, LACTIC, ENZYMATIC METHOD,GLUCO ELECTRODE, ION BASED, ENZYMATIC, CREATININE,ACID, LACTIC, ENZYMATIC METHOD,GLUCOSE OXIDASE, GLUCOSE | 1 | StatSensor/StatStrip |
| 9 | 00385480519960 | 1.0 | 51996 | Statsensor Statstrip Docking Station 4 position | CGL,KHP,CGA | ELECTRODE, ION BASED, ENZYMATIC, CREATININE,ACID, LACTIC, ENZYMATIC METHOD,GLUCO ELECTRODE, ION BASED, ENZYMATIC, CREATININE,ACID, LACTIC, ENZYMATIC METHOD,GLUCOSE OXIDASE, GLUCOSE | 1 | StatSensor/StatStrip |
| 10 | 00385480519953 | 1.0 | 51995 | Statsensor Statstrip Docking Station 2 position | CGA,KHP,CGL | GLUCOSE OXIDASE, GLUCOSE,ACID, LACTIC, ENZYMATIC METHOD,ELECTRODE, ION BASED, EN GLUCOSE OXIDASE, GLUCOSE,ACID, LACTIC, ENZYMATIC METHOD,ELECTRODE, ION BASED, ENZYMATIC, CREATININE | 1 | StatSensor/StatStrip |
| 11 | 00385480519946 | 1.0 | 51994 | Statsensor Statstrip Docking Station | KHP,CGA,CGL | ACID, LACTIC, ENZYMATIC METHOD,GLUCOSE OXIDASE, GLUCOSE,ELECTRODE, ION BASED, EN ACID, LACTIC, ENZYMATIC METHOD,GLUCOSE OXIDASE, GLUCOSE,ELECTRODE, ION BASED, ENZYMATIC, CREATININE | 1 | StatSensor/StatStrip |
| 12 | 00385480517560 | 1.0 | 51756 | StatSensor StatStrip Docking Station Remanufactured | CGA,KHP,CGL | GLUCOSE OXIDASE, GLUCOSE,ACID, LACTIC, ENZYMATIC METHOD,ELECTRODE, ION BASED, EN GLUCOSE OXIDASE, GLUCOSE,ACID, LACTIC, ENZYMATIC METHOD,ELECTRODE, ION BASED, ENZYMATIC, CREATININE | 1 | StatSensor/StatStrip |
| 13 | 00385480506687 | 1.0 | 50668 | StatSensor Creatinine Meter with Battery and Quick Reference Guide | CGL | ELECTRODE, ION BASED, ENZYMATIC, CREATININE | 2 | StatSensor |
| 14 | 00385480486309 | 1.0 | 48630 | StatSensor StatStrip Wireless Carrying Case for Meter and Supplies | KHP,CGL,CGA | ACID, LACTIC, ENZYMATIC METHOD,ELECTRODE, ION BASED, ENZYMATIC, CREATININE,GLUCO ACID, LACTIC, ENZYMATIC METHOD,ELECTRODE, ION BASED, ENZYMATIC, CREATININE,GLUCOSE OXIDASE, GLUCOSE | 1 | StatSensor/StatStrip |
| 15 | 00385480486293 | 1.0 | 48629 | StatSensor StatStrip Docking Station for Wireless Carrying Case | CGA,CGL,KHP | GLUCOSE OXIDASE, GLUCOSE,ELECTRODE, ION BASED, ENZYMATIC, CREATININE,ACID, LACTI GLUCOSE OXIDASE, GLUCOSE,ELECTRODE, ION BASED, ENZYMATIC, CREATININE,ACID, LACTIC, ENZYMATIC METHOD | 1 | StatSensor/StatStrip |
| 16 | 00385480453356 | 1.0 | 45335 | StatSensor Creatinine Meter with Quick Reference Guide - Remanufactured | CGL | ELECTRODE, ION BASED, ENZYMATIC, CREATININE | 2 | StatSensor |
| 17 | 00385480440523 | 1.0 | 44052 | StatSensor Creatinine Meter with Battery and Quick Reference Guide | CGL | ELECTRODE, ION BASED, ENZYMATIC, CREATININE | 2 | StatSensor |
| 18 | 00385480440370 | Creatinine | 44037 | StatSensor Creat Linearity Level 1 - 5 | JJX | Single (specified) analyte controls (assayed and unassayed) | StatSensor | |
| 19 | 00385480438063 | 1.0 | 43806 | StatSensor Stat Strip Docking Station Non Network Capable | CGL,CGA,KHP | ELECTRODE, ION BASED, ENZYMATIC, CREATININE,GLUCOSE OXIDASE, GLUCOSE,ACID, LACTI ELECTRODE, ION BASED, ENZYMATIC, CREATININE,GLUCOSE OXIDASE, GLUCOSE,ACID, LACTIC, ENZYMATIC METHOD | 1 | StatSensor/StatStrip |
| 20 | 00385480422253 | 1.0 | 42225 | StatSensor StatStrip Docking Station | CGA,CGL,KHP | GLUCOSE OXIDASE, GLUCOSE,ELECTRODE, ION BASED, ENZYMATIC, CREATININE,ACID, LACTI GLUCOSE OXIDASE, GLUCOSE,ELECTRODE, ION BASED, ENZYMATIC, CREATININE,ACID, LACTIC, ENZYMATIC METHOD | 1 | StatSensor/StatStrip |
| 21 | 00385480173605 | 16 | 17360 | NOVA 16 CREATININE SENSOR | CGL | ELECTRODE, ION BASED, ENZYMATIC, CREATININE | 2 | NOVA |
| 22 | 00385480173599 | 16 | 17359 | NOVA 16 GLUCOSE SENSOR | CGA | GLUCOSE OXIDASE, GLUCOSE | 2 | NOVA |
| 23 | 00385480172899 | 16 | 17289 | NOVA 16 Na+, Cl-, TCo2, Glu, CREAT, BUN,HCt | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | NOVA |
| 24 | 00385480170932 | 16 | 17093 | NOVA 16 TUBING HARNESS WITHOUT DILUTOR | CGZ,JJC,CGL,JIX,JPI,CDS,JFL,JPK,CEM,CGA | ELECTRODE, ION-SPECIFIC, CHLORIDE,ANALYZER, CHEMISTRY (SEQUENTIAL MULTIPLE, CONT ELECTRODE, ION-SPECIFIC, CHLORIDE,ANALYZER, CHEMISTRY (SEQUENTIAL MULTIPLE, CONTINUOUS FLOW) CLINICAL USE,ELECTRODE, ION BASED, ENZYMATIC, CREATININE,CALIBRATOR, MULTI-ANALYTE MIXTURE,DEVICE, HEMATOCRIT MEASURING,ELECTRODE, ION SPECIFIC, UREA NITROGEN,PH RATE MEASUREMENT, CARBON-DIOXIDE,MIXTURE, HEMATOLOGY QUALITY CONTROL,ELECTRODE, ION SPECIFIC, POTASSIUM,GLUCOSE OXIDASE, GLUCOSE | 1 | NOVA |
| 25 | 00385480170925 | 16 | 17092 | NOVA 16 TUBING HARNESS WITH DILUTOR | JJC,CGZ,JIX,CDS,JPK,JFL,CGA,CGL,CEM,JPI | ANALYZER, CHEMISTRY (SEQUENTIAL MULTIPLE, CONTINUOUS FLOW) CLINICAL USE,ELECTROD ANALYZER, CHEMISTRY (SEQUENTIAL MULTIPLE, CONTINUOUS FLOW) CLINICAL USE,ELECTRODE, ION-SPECIFIC, CHLORIDE,CALIBRATOR, MULTI-ANALYTE MIXTURE,ELECTRODE, ION SPECIFIC, UREA NITROGEN,MIXTURE, HEMATOLOGY QUALITY CONTROL,PH RATE MEASUREMENT, CARBON-DIOXIDE,GLUCOSE OXIDASE, GLUCOSE,ELECTRODE, ION BASED, ENZYMATIC, CREATININE,ELECTRODE, ION SPECIFIC, POTASSIUM,DEVICE, HEMATOCRIT MEASURING | 1 | NOVA |
| 26 | 00385480167291 | 1/5/11/13 | 16729 | NOVA 1/5/11/13 TUBING HARNESS WITH DILUTOR | CEM,JPI,JGS,NDW,CGZ | ELECTRODE, ION SPECIFIC, POTASSIUM,DEVICE, HEMATOCRIT MEASURING,ELECTRODE, ION S ELECTRODE, ION SPECIFIC, POTASSIUM,DEVICE, HEMATOCRIT MEASURING,ELECTRODE, ION SPECIFIC, SODIUM,Assay, porphyrin, spectrophotometry, lithium,ELECTRODE, ION-SPECIFIC, CHLORIDE | 2 | NOVA |
| 27 | 00385480167284 | 1/5/11/13 | 16728 | NOVA 1/5/11/13 TUBING HARNESS WITHOUT DILUTOR | CGZ,JGS,NDW,JPI,CEM | ELECTRODE, ION-SPECIFIC, CHLORIDE,ELECTRODE, ION SPECIFIC, SODIUM,Assay, porphyr ELECTRODE, ION-SPECIFIC, CHLORIDE,ELECTRODE, ION SPECIFIC, SODIUM,Assay, porphyrin, spectrophotometry, lithium,DEVICE, HEMATOCRIT MEASURING,ELECTRODE, ION SPECIFIC, POTASSIUM | 2 | NOVA |
| 28 | 00385480165013 | 4/10/12 | 16501 | NOVA 4/10/12 AIR DETECTOR | JFP,CGA,CDS,NDW,JFL,CEM,JGS,CGZ | ELECTRODE, ION SPECIFIC, CALCIUM,GLUCOSE OXIDASE, GLUCOSE,ELECTRODE, ION SPECIFI ELECTRODE, ION SPECIFIC, CALCIUM,GLUCOSE OXIDASE, GLUCOSE,ELECTRODE, ION SPECIFIC, UREA NITROGEN,Assay, porphyrin, spectrophotometry, lithium,PH RATE MEASUREMENT, CARBON-DIOXIDE,ELECTRODE, ION SPECIFIC, POTASSIUM,ELECTRODE, ION SPECIFIC, SODIUM,ELECTRODE, ION-SPECIFIC, CHLORIDE | 2 | NOVA |
| 29 | 00385480164832 | 16 | 16483 | NOVA 16 GLUCOSE MEMBRANE KIT: REFRIGERATE | CGA | GLUCOSE OXIDASE, GLUCOSE | NOVA | |
| 30 | 00385480161534 | 12/14 | 16153 | NOVA 12/14 GLU/BUN SENSOR BLANK | CDS,CGA | ELECTRODE, ION SPECIFIC, UREA NITROGEN,GLUCOSE OXIDASE, GLUCOSE | 2 | NOVA |
| 31 | 00385480161381 | 10 | 16138 | NOVA 10 URINE DILUENT | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | NOVA |
| 32 | 00385480158190 | 12 | 15819 | NOVA 12, NOVA 14, NOVA 16 DILUTER PACK | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | NOVA |
| 33 | 00385480157421 | 4/10/11/13 | 15742 | NOVA 4/10/11/13 LITHIUM SENSOR | NDW | Assay, porphyrin, spectrophotometry, lithium | 2 | NOVA |
| 34 | 00385480156516 | 13 | 15651 | NOVA 13 Na+, K+, Cl-, Li+, Hct | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | NOVA |
| 35 | 00385480156509 | 12 | 15650 | NOVA 12 Na+, K+, Cl-, TCO2, Glu, BUN | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | NOVA |
| 36 | 00385480156493 | 11 | 15649 | NOVA 11 Na+, K+, Li+, Hct | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | NOVA |
| 37 | 00385480156486 | 5 | 15648 | NOVA 5 Na+, K+, Cl-, HCt CALIBRATOR | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | NOVA |
| 38 | 00385480156479 | 4 | 15647 | NOVA 4 Na+, K+, Cl-, TCo2, KL+ CALIBRATORS | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | NOVA |
| 39 | 00385480156462 | 1 | 15646 | NOVA 1 Na+, K+, HCt | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | NOVA |
| 40 | 00385480152792 | 10 | 15279 | NOVA 10 TOTAL CALCIUM SENSOR | JFP | ELECTRODE, ION SPECIFIC, CALCIUM | 2 | NOVA |
| 41 | 00385480152655 | 8 | 15265 | NOVA 8 IONIZED MAGNESIUM SENSOR | CFA | ELECTRODE, ION SPECIFIC, MAGNESIUM | 1 | NOVA |
| 42 | 00385480152648 | 8 | 15264 | NOVA 8 IONIZED CALCIUM SENSOR | JFP | ELECTRODE, ION SPECIFIC, CALCIUM | 2 | NOVA |
| 43 | 00385480152631 | 8 | 15263 | NOVA 8 pH SENSOR | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | NOVA |
| 44 | 00385480152150 | 8 | 15215 | Nova 8/8+ Analyzer w/ Printer (no Acc Pack) | JGS,JFP,CHL,CFA,CEM,JPI | ELECTRODE, ION SPECIFIC, SODIUM,ELECTRODE, ION SPECIFIC, CALCIUM,ELECTRODE MEASU ELECTRODE, ION SPECIFIC, SODIUM,ELECTRODE, ION SPECIFIC, CALCIUM,ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH,ELECTRODE, ION SPECIFIC, MAGNESIUM,ELECTRODE, ION SPECIFIC, POTASSIUM,DEVICE, HEMATOCRIT MEASURING | 1 | NOVA |
| 45 | 00385480146098 | 14 | 14609 | NOVA 14 Na+, K+, Cl-, Glu, BUN, Hct | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | NOVA |
| 46 | 00385480146081 | 10 | 14608 | NOVA 10 Na+, K+, Cl-, TCa | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | NOVA |
| 47 | 00385480142533 | CRT | 14253 | Microsample Tube Kit 50 ul Nova CRT | JJC,NDW,JPK,JIX,CEM,JPI,CFA,CGL,JFL,JFP,CGA,JGS,CDS,CGZ | ANALYZER, CHEMISTRY (SEQUENTIAL MULTIPLE, CONTINUOUS FLOW) CLINICAL USE,Assay, p ANALYZER, CHEMISTRY (SEQUENTIAL MULTIPLE, CONTINUOUS FLOW) CLINICAL USE,Assay, porphyrin, spectrophotometry, lithium,MIXTURE, HEMATOLOGY QUALITY CONTROL,CALIBRATOR, MULTI-ANALYTE MIXTURE,ELECTRODE, ION SPECIFIC, POTASSIUM,DEVICE, HEMATOCRIT MEASURING,ELECTRODE, ION SPECIFIC, MAGNESIUM,ELECTRODE, ION BASED, ENZYMATIC, CREATININE,PH RATE MEASUREMENT, CARBON-DIOXIDE,ELECTRODE, ION SPECIFIC, CALCIUM,GLUCOSE OXIDASE, GLUCOSE,ELECTRODE, ION SPECIFIC, SODIUM,ELECTRODE, ION SPECIFIC, UREA NITROGEN,ELECTRODE, ION-SPECIFIC, CHLORIDE | NOVA | |
| 48 | 00385480142441 | 1/4/5/8/10/11/12/13/14 | 14244 | NOVA 1/4/5/8/10/11/12/13/14 REFERENCE SENSOR | JIX,JFL,CFA,JJC,CGZ,JPI,CEM,NDW,CDS,JGS,CGA,JFP,JPK | CALIBRATOR, MULTI-ANALYTE MIXTURE,PH RATE MEASUREMENT, CARBON-DIOXIDE,ELECTRODE, CALIBRATOR, MULTI-ANALYTE MIXTURE,PH RATE MEASUREMENT, CARBON-DIOXIDE,ELECTRODE, ION SPECIFIC, MAGNESIUM,ANALYZER, CHEMISTRY (SEQUENTIAL MULTIPLE, CONTINUOUS FLOW) CLINICAL USE,ELECTRODE, ION-SPECIFIC, CHLORIDE,DEVICE, HEMATOCRIT MEASURING,ELECTRODE, ION SPECIFIC, POTASSIUM,Assay, porphyrin, spectrophotometry, lithium,ELECTRODE, ION SPECIFIC, UREA NITROGEN,ELECTRODE, ION SPECIFIC, SODIUM,GLUCOSE OXIDASE, GLUCOSE,ELECTRODE, ION SPECIFIC, CALCIUM,MIXTURE, HEMATOLOGY QUALITY CONTROL | 1 | NOVA |
| 49 | 00385480141871 | 4 | 14187 | NOVA 4 TUBING HARNESS WITHOUT DILUTOR | NDW,CGZ,CEM,JFL,JGS | Assay, porphyrin, spectrophotometry, lithium,ELECTRODE, ION-SPECIFIC, CHLORIDE,E Assay, porphyrin, spectrophotometry, lithium,ELECTRODE, ION-SPECIFIC, CHLORIDE,ELECTRODE, ION SPECIFIC, POTASSIUM,PH RATE MEASUREMENT, CARBON-DIOXIDE,ELECTRODE, ION SPECIFIC, SODIUM | 2 | NOVA |
| 50 | 00385480141826 | 1/4/5/8/10/11/12/13/14/16 | 14182 | Nova 1/4/5/8/10/11/12/13/14/16 Sensor Seal Kit | CFA,CDS,JGS,CGZ,NDW,JFL,CGA,CGL,CEM,JPI,JFP,JPK,JIX,JJC | ELECTRODE, ION SPECIFIC, MAGNESIUM,ELECTRODE, ION SPECIFIC, UREA NITROGEN,ELECTR ELECTRODE, ION SPECIFIC, MAGNESIUM,ELECTRODE, ION SPECIFIC, UREA NITROGEN,ELECTRODE, ION SPECIFIC, SODIUM,ELECTRODE, ION-SPECIFIC, CHLORIDE,Assay, porphyrin, spectrophotometry, lithium,PH RATE MEASUREMENT, CARBON-DIOXIDE,GLUCOSE OXIDASE, GLUCOSE,ELECTRODE, ION BASED, ENZYMATIC, CREATININE,ELECTRODE, ION SPECIFIC, POTASSIUM,DEVICE, HEMATOCRIT MEASURING,ELECTRODE, ION SPECIFIC, CALCIUM,MIXTURE, HEMATOLOGY QUALITY CONTROL,CALIBRATOR, MULTI-ANALYTE MIXTURE,ANALYZER, CHEMISTRY (SEQUENTIAL MULTIPLE, CONTINUOUS FLOW) CLINICAL USE | NOVA |
| 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 | 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. |
| 3 | 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. |
| 4 | 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. |
| 5 | 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. |
| 6 | 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. |
| 7 | 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. |
| 8 | 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. |
| 9 | 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. |
| 10 | 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. |
| 11 | 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. |
| 12 | 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. |
| 13 | 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. |
| 14 | 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. |
| 15 | 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. |
| 16 | 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. |
| 17 | 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. |
| 18 | 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. |
| 19 | 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. |
| 20 | EABA10090201 | 100-9020 | 100-9020 | BRT Chemistry Control is a human liquid assayed or control serum to monitor the BRT Chemistry Control is a human liquid assayed or control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert for the Abaxis Piccolo Express®. | BRT Liquid Assayed Chemistry Control with CRP | BIORESOURCE TECHNOLOGY |
| 21 | EABA10090101 | 100-9010 | 100-9010 | BRT Chemistry Control is a human liquid assayed or control serum to monitor the BRT Chemistry Control is a human liquid assayed or control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert for the Abaxis Piccolo Express®. | BRT Liquid Assayed Chemistry Control | BIORESOURCE TECHNOLOGY |
| 22 | 00884883012004 | OCRD-MP | MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control | MICROGENICS CORPORATION | ||
| 23 | 00884883011991 | OCRD-SP | MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control | MICROGENICS CORPORATION | ||
| 24 | 00884883011984 | OCRD-303 | MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control | MICROGENICS CORPORATION | ||
| 25 | 00884883011977 | OCRD-202 | MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control | MICROGENICS CORPORATION | ||
| 26 | 00884883011960 | OCRD-101 | MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control | MICROGENICS CORPORATION | ||
| 27 | 00884883011953 | OCRD-L | MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control | MICROGENICS CORPORATION | ||
| 28 | 00884883011946 | OCRD-UL | MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control | MICROGENICS CORPORATION | ||
| 29 | 00884883011601 | IC-V3 | MAS Immunology Liquid Assayed Immunology Control | MICROGENICS CORPORATION | ||
| 30 | 00884883011595 | IC-V2 | MAS Immunology Liquid Assayed Immunology Control | MICROGENICS CORPORATION | ||
| 31 | 00884883011588 | IC-V1 | MAS Immunology Liquid Assayed Immunology Control | MICROGENICS CORPORATION | ||
| 32 | 00884883006362 | URN5005 | SENTRY Urine Dipstick Control | MICROGENICS CORPORATION | ||
| 33 | 00884883005433 | OCR-SP | MAS Omni-CORE Liquid Assayed Integrated Chemistry Control | MICROGENICS CORPORATION | ||
| 34 | 00884883005426 | OCR-303 | MAS Omni-CORE Liquid Assayed Integrated Chemistry Control | MICROGENICS CORPORATION | ||
| 35 | 00884883005419 | OCR-202 | MAS Omni-CORE Liquid Assayed Integrated Chemistry Control | MICROGENICS CORPORATION | ||
| 36 | 00884883005402 | OCR-101 | MAS Omni-CORE Liquid Assayed Integrated Chemistry Control | MICROGENICS CORPORATION | ||
| 37 | 00884883005396 | OIM-SP | MAS Omni-IMMUNE Liquid Assayed Integrated Immunoassay Control | MICROGENICS CORPORATION | ||
| 38 | 00884883005389 | OIM-303 | MAS Omni-IMMUNE Liquid Assayed Integrated Immunoassay Control | MICROGENICS CORPORATION | ||
| 39 | 00884883005372 | OIM-202 | MAS Omni-IMMUNE Liquid Assayed Integrated Immunoassay Control | MICROGENICS CORPORATION | ||
| 40 | 00884883005365 | OIM-101 | MAS Omni-IMMUNE Liquid Assayed Integrated Immunoassay Control | MICROGENICS CORPORATION | ||
| 41 | 00884883005358 | OPRO-SP | MAS Omni-IMMUNE PRO Liquid Assayed Integrated Immunoassay Control | MICROGENICS CORPORATION | ||
| 42 | 00884883005341 | OPRO-303 | MAS Omni-IMMUNE PRO Liquid Assayed Integrated Immunoassay Control | MICROGENICS CORPORATION | ||
| 43 | 00884883005334 | OPRO-202 | MAS Omni-IMMUNE PRO Liquid Assayed Integrated Immunoassay Control | MICROGENICS CORPORATION | ||
| 44 | 00884883005327 | OPRO-101 | MAS Omni-IMMUNE PRO Liquid Assayed Integrated Immunoassay Control | MICROGENICS CORPORATION | ||
| 45 | 00884883004467 | 10014443 | MAS Alcohol/Ammonia | MICROGENICS CORPORATION | ||
| 46 | 00884883004412 | 10014444 | MAS CSF Liquid Assayed Cerebral Spinal Fluid | MICROGENICS CORPORATION | ||
| 47 | 00884883004399 | 10014182 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | MICROGENICS CORPORATION | ||
| 48 | 00884883004382 | 10014181 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | MICROGENICS CORPORATION | ||
| 49 | 00884883004375 | 10014180 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | MICROGENICS CORPORATION | ||
| 50 | 00884883004368 | 10014179 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | MICROGENICS CORPORATION |