Other products from "NOVA BIOMEDICAL CORPORATION"
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
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19 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.
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23 EABA40000301 400-0030 400-0030 The Piccolo® Lipid Panel Plus, used with the Piccolo® blood chemistry analyzer o The Piccolo® Lipid Panel Plus, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended for the in vitro quantitative determination of total cholesterol (CHOL), high-density lipoprotein cholesterol (HDL), triglycerides (TRIG), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and glucose (GLU) in capillary (fingerstick) lithium heparinized whole blood, venous lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. From the CHOL, HDL and TRIG determinations, low-density lipoprotein cholesterol (LDL), very low-density lipoprotein cholesterol (VLDL), non-HDL cholesterol, and a total cholesterol/high-density lipoprotein cholesterol ratio (TC/H) are calculated by the analyzer.Lipid measurements are used in the diagnosis and treatment of lipid and lipoprotein disorders, atherosclerosis, various liver and renal diseases, diabetes mellitus, and other diseases involving lipid metabolism or various endocrine disorders.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 (venous or capillary) may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. Piccolo Lipid Panel Plus ABAXIS, INC.
24 EABA40000291 400-0029 400-0029 The Piccolo® General Chemistry 13 used with the Piccolo blood chemistry analyzer The Piccolo® General Chemistry 13 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), amylase, aspartate aminotransferase (AST), calcium, creatinine, gamma glutamyltransferase (GGT), glucose, total bilirubin, total protein, blood urea nitrogen (BUN), and uric acid 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 General Chemistry 13 ABAXIS, INC.
25 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.
26 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.
27 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.
28 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.
29 EABA40000061 400-0006 400-0006 The Piccolo® General Chemistry 6 , used with the Piccolo® blood chemistry analyz The Piccolo® General Chemistry 6 , 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), aspartate aminotransferase (AST), creatinine, gamma glutamyltransferase (GGT), glucose, 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 General Chemistry 6 ABAXIS, INC.
30 00887473000160 01GS11 SD GlucoNavii Blood Glucose Test Strip SD BIOSENSOR, INC.
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36 00885502001041 IGM-0009 IGM-G3-103 Control™ Meter Kit U.S. DIAGNOSTICS INC.
37 00885502001034 IGM-0008 IGM-G2-103 EasyGluco™G2 Meter Kit U.S. DIAGNOSTICS INC.
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