Other products from "POINTE SCIENTIFIC, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00811727018335 60-MP0706-5 60-MP0706-5 Pointe Methamphetamine Calibrator (500 ng/mL) Cutoff 1 x 5 mL The Pointe Methamp Pointe Methamphetamine Calibrator (500 ng/mL) Cutoff 1 x 5 mL The Pointe Methamphetamine Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Methamphetamine Reagent Set (Ref# 60-MP0700-100/60-MP0700-1L) on a number of automated clinical chemistry analyzers. DLJ Calibrators, Drug Specific 2 Pointe Methamphetamine Calibrator (500 ng/mL) Cutoff
2 00811727017987 60-PP0256-5 60-PP0256-5 Pointe Propoxyphene (PPX) Control (375 ng/mL) Level 2 1 x 5 mL The Pointe Propox Pointe Propoxyphene (PPX) Control (375 ng/mL) Level 2 1 x 5 mL The Pointe Propoxyphene (PPX) Controls are for use as assayed quality control materials to monitor the precision of the Pointe Propoxyphene (PPX) Reagent Set (Ref# 60-PP0240-100/60-PP0240-1L) on a number of automated clinical chemistry analyzers. LAS Drug Specific Control Materials 1 Pointe Propoxyphene (PPX) Control (375 ng/mL) Level 2
3 00811727017970 60-PP0254-5 60-PP0254-5 Pointe Propoxyphene (PPX) Control (225 ng/mL) Level 1 1 x 5 mL The Pointe Propox Pointe Propoxyphene (PPX) Control (225 ng/mL) Level 1 1 x 5 mL The Pointe Propoxyphene (PPX) Controls are for use as assayed quality control materials to monitor the precision of the Pointe Propoxyphene (PPX) Reagent Set (Ref# 60-PP0240-100/60-PP0240-1L) on a number of automated clinical chemistry analyzers. LAS Drug Specific Control Materials 1 Pointe Propoxyphene (PPX) Control (225 ng/mL) Level 1
4 00811727015822 14-HB936-200 14-HB936-200 Pointe Direct Bilirubin Reagent packaged for the BS480 analyzer. 4x40mL, 4x10mL Pointe Direct Bilirubin Reagent packaged for the BS480 analyzer. 4x40mL, 4x10mL Kit. For the quantitative determination of direct bilirubin in serum on the BS480 analyzers. For in vitro diagnostic use only. CIG Diazo Colorimetry, Bilirubin 2 Pointe Direct Bilirubin for BS480
5 00811727017550 60-MA1704-15 60-MA1704-15 Pointe Multi-Analyte Set C Urine DAU Low Calibrator 1 x 15 mL The Pointe Multi-A Pointe Multi-Analyte Set C Urine DAU Low Calibrator 1 x 15 mL The Pointe Multi-Analyte Set C Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of drugs of abuse enzyme immunoassays for the detection of cocaine metabolite, d-methamphetamine, methadone, morphine, oxazepam, and secobarbital in human urine on a number of automated clinical chemistry analyzers. DKB Calibrators, Drug Mixture 2 Pointe Multi-Analyte Set C Urine DAU Low Calibrator
6 00811727015778 14-C7510-480 14-C7510-480 Pointe Cholesterol packaged to use on the BS480 Analyzer. 8x60mL Kit. For the qu Pointe Cholesterol packaged to use on the BS480 Analyzer. 8x60mL Kit. For the quantitative determination of Total Cholesterol in serum. For in vitro diagnostic use. CHH Enzymatic Esterase--Oxidase, Cholesterol 1 Pointe Cholesterol on BS480
7 00811727011060 C7568-CTL C7568-CTL These C-Reactive Protein Controls are intended for use in C-Reactive Protein (Hi These C-Reactive Protein Controls are intended for use in C-Reactive Protein (High Sensitivity) Wide Range test systems to validate performance of the assay. The controls may also be useful in assessing test precision or analytical errors.2 For in vitro diagnostic use only. DCK C-Reactive Protein, Antigen, Antiserum, And Control 2 POINTE SCIENTIFIC CRP Control Set
8 00811727010575 B7550-STD B7550-STD Intended for use as an BUN (Urea Nitrogen) standard for standardization or calib Intended for use as an BUN (Urea Nitrogen) standard for standardization or calibration of Urease/GLDH, BUN (Urea Nitrogen) procedures. CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen 2 POINTE SCIENTIFIC BUN Standard
9 00811727010391 A7561-625 A7561-625 For the quantitative determination of Aspartate Aminotransferase (AST) in human serum. POINTE SCIENTIFIC AST (SGOT) Liquid
10 00811727010384 A7561-450 A7561-450 For the quantitative determination of Aspartate Aminotransferase (AST) in human serum. CIT Nadh Oxidation/Nad Reduction, Ast/Sgot 2 POINTE SCIENTIFIC AST (SGOT) Liquid
11 00811727010377 A7561-150 A7561-150 For the quantitative determination of Aspartate Aminotransferase (AST) in human serum. CIT Nadh Oxidation/Nad Reduction, Ast/Sgot 2 POINTE SCIENTIFIC AST (SGOT) Liquid
12 00811727013040 HI904-498 HI904-498 Iron Reagent is for the quantitative determination of iron (ferrozine) in serum Iron Reagent is for the quantitative determination of iron (ferrozine) in serum on Hitachi analyzers. For in vitro diagnostic use only.6 x 66ml, 6 x 17ml JIY Photometric Method, Iron (Non-Heme) 1 Pointe Scientific Inc. Iron
13 00811727012999 HC922-300 HC922-300 CK Reagent is for the quantitative determination of creatine kinase activity in CK Reagent is for the quantitative determination of creatine kinase activity in serum on Hitachi analyzers. CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes 2 Pointe Scientific, Inc. CK
14 00811727017406 60-EA0440-1L 60-EA0440-1L Pointe Ethyl Alcohol Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Ethyl Pointe Ethyl Alcohol Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Ethyl Alcohol Reagent Set is intended for the quantitative determination of ethyl alcohol in human urine, serum or plasma. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method 2 Pointe Ethyl Alcohol Reagent Set
15 00811727017390 60-EA0440-100 60-EA0440-100 Pointe Ethyl Alcohol Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Ethyl Pointe Ethyl Alcohol Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Ethyl Alcohol Reagent Set is intended for the quantitative determination of ethyl alcohol in human urine, serum or plasma. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method 2 Pointe Ethyl Alcohol Reagent Set
16 00811727011886 M7562-100 M7562-100 Pointe Scientific, Inc. Microalbumin Reagent for the quantitative determination Pointe Scientific, Inc. Microalbumin Reagent for the quantitative determination of low levels of albumin in urine by immunoturbidimetric assay. For in vitro diagnostic use.4 x 20 ml., 2 x 10 ml. JIT,DDZ Calibrator, Secondary,Albumin, Fitc, Antigen, Antiserum, Control 2 Pointe Scientific, Inc. Microalbumin
17 00811727016034 16-HA965-223 16-HA965-223 Pointe Amylase Reagent packaged for use on the Mindray BA800. 3 x 63ml R1, 2 x Pointe Amylase Reagent packaged for use on the Mindray BA800. 3 x 63ml R1, 2 x 17ml R2. For the quantitative kinetic determination of a-amylase activity in human serum. For in vitro diagnostic use only. CIJ Saccharogenic, Amylase 2 Pointe Amylase Reagent
18 00811727016072 16-C7548-240 16-C7548-240 Pointe Creatinine, Enzymatic Reagent packaged for use on the Mindray BA800. 3 x Pointe Creatinine, Enzymatic Reagent packaged for use on the Mindray BA800. 3 x 60ml R1, 3 x 20ml R2. For the quantitative determination of C-reactive protein in serum or plasma by latex particle enhanced immunoturbidimetric assay. For in vitro diagnostic use only. JFY Enzymatic Method, Creatinine 2 Pointe Creatinine, Enzymatic Reagent
19 00811727015907 14-L7572-200 14-L7572-200 Pointe Lactate Dehydrogenase Reagent packaged for use on the Mindray BS480. 4 x Pointe Lactate Dehydrogenase Reagent packaged for use on the Mindray BS480. 4 x 40ml R1, 4 x 10ml R2. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase 2 Pointe Lactate Dehydrogenase Reagent
20 00811727015884 14-HI904-350 14-HI904-350 Pointe Total Iron Reagent packaged for use on the BS480 Analyzer. 5x58mL Buffer, Pointe Total Iron Reagent packaged for use on the BS480 Analyzer. 5x58mL Buffer, 5x12mL Color Kit. For the quantitative determination of iron and total iron-binding capacity in serum. For in vitro diagnostic use only. JIY Photometric Method, Iron (Non-Heme) 1 Pointe Total Iron for the BS480
21 00811727015211 T8007-96 T8007-96 Pointe Scientific, Inc. HSV-1 & 2 IgG Reagent is for the qualitative, and semi-q Pointe Scientific, Inc. HSV-1 & 2 IgG Reagent is for the qualitative, and semi-quantitative detection of human IgG antibodies to type 1 and type 2 herpes simplex virus (HSV) in human serum by enzyme immunoassay. To aid in the evaluation of the patient's immunological history with HSV, including women of childbearing age. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests. LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific 2 Pointe Scientific, Inc. HSV-1 & 2 IgG
22 00811727015051 OH945-480 OH945-480 Pointe Scientific, Inc. autoHDL Cholesterol Reagent is for the quantitative dete Pointe Scientific, Inc. autoHDL Cholesterol Reagent is for the quantitative determination high-density lipoprotein cholesterol in human serum or plasma. For in vitro diagnostic use only. Packaged for use on Olympus Analyzers. 6 x 60ml, 6 x 20ml LBR Ldl & Vldl Precipitation, Hdl 1 Pointe Scientific, Inc. autoHDL Cholesterol
23 00811727014979 OC702-180 OC702-180 Pointe Scientific, Inc. Carbon Dioxide Reagent is for the quantitative determina Pointe Scientific, Inc. Carbon Dioxide Reagent is for the quantitative determination of Carbon Dioxide in serum, packaged for use on Olympus analyzers. For in vitro diagnostic use only.4 x 45ml KHS Enzymatic, Carbon-Dioxide 2 Pointe Scientific, Inc. Carbon Dioxide
24 00811727014955 OB952-482 OB952-482 Pointe Scientific, Inc. BUN Reagent is for the quantitative determination of ure Pointe Scientific, Inc. BUN Reagent is for the quantitative determination of urea nitrogen in serum on Olympus Analyzers. For in vitro diagnostic use only.6 x 66ml, 2 x 43ml CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen 2 Pointe Scientific, Inc. BUN
25 00811727014924 OA961-487 OA961-487 Pointe Scientific, Inc. AST Reagent is for the quantitative determination of Asp Pointe Scientific, Inc. AST Reagent is for the quantitative determination of Aspartate Aminotransferase (AST) in human serum. Packaged with barcodes for use on AU400, AU480 and AU640.6 x 67ml, 5 x 17ml CIT Nadh Oxidation/Nad Reduction, Ast/Sgot 2 Pointe Scientific, Inc. AST
26 00811727014900 OA902-702 OA902-702 Pointe Scientific, Inc. Alkaline Phosphatase Reagent is for the quantitative det Pointe Scientific, Inc. Alkaline Phosphatase Reagent is for the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. Packaged with barcodes for use on AU400, AU480 and AU640.5 x 50ml, 4 x 13ml. Pointe Scientific, Inc. Alkaline Phosphatase
27 00811727014771 HL956-1400 HL956-1400 Pointe Lactate Dehydrogenase Reagent is for the quantitative kinetic determinati Pointe Lactate Dehydrogenase Reagent is for the quantitative kinetic determination of lactate dehydrogenase activity in serum on Hitachi analyzers. For in vitro diagnostic use only.1 x 1L, 1 x 400ml CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase 2 Pointe Scientific, Inc. LD
28 00811727011091 F7546-CTL F7546-CTL These Fructosamine Controls are intended for use in fructosamine test systems to These Fructosamine Controls are intended for use in fructosamine test systems to validate performance of the assay. The controls may also be useful in assessing test precision or analytical errors.1 For in vitro diagnostic use only. LCP Assay, Glycosylated Hemoglobin 2 POINTE SCIENTIFIC Fructosamine Control Set
29 00811727017031 60-ME0220-1L 60-ME0220-1L Pointe Methadone Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Methadone Pointe Methadone Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Methadone Reagent Set is intended for the qualitative and semi-quantitative determination of methadone in human urine at a cutoff value of 300 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. DJR Enzyme Immunoassay, Methadone 2 Pointe Methadone Reagent Set
30 00811727014245 13-G7540-STD 13-G7540-STD This product is for the purpose of standardizing results obtained from run to ru This product is for the purpose of standardizing results obtained from run to run in the quantitative determination of human glycohemoglobin (HbA1) in blood by cation exchange resin.1 x 1 ml LCP Assay, Glycosylated Hemoglobin 2 Pointe Scientific, Inc. Glyco Standard
31 00811727014214 13-G7521-1000 13-G7521-1000 Reagent for the quantitative determination of Glucose in serum. For in vitro di Reagent for the quantitative determination of Glucose in serum. For in vitro diagnostic use only.1 x 1000 ml CGA Glucose Oxidase, Glucose 2 Pointe Scientific, Inc. Glucose Ox
32 00811727014207 13-G7521-500 13-G7521-500 Reagent for the quantitative determination of Glucose in serum. For in vitro di Reagent for the quantitative determination of Glucose in serum. For in vitro diagnostic use only.1 x 500 ml CGA Glucose Oxidase, Glucose 2 Pointe Scientific, Inc. Glucose Ox
33 00811727014191 13-G7521-120 13-G7521-120 Reagent for the quantitative determination of Glucose in serum. For in vitro di Reagent for the quantitative determination of Glucose in serum. For in vitro diagnostic use only.1 x 120 ml CGA Glucose Oxidase, Glucose 2 Pointe Scientific, Inc. Glucose Ox
34 00811727014184 13-G7518-STD 13-G7518-STD Reagent intended for use as an glucose standard for standardization or calibrati Reagent intended for use as an glucose standard for standardization or calibration of glucose hexokinase or oxidase procedures.1 x 100 mg/dl CGA Glucose Oxidase, Glucose 2 Pointe Scientific, Inc. Glucose Standard
35 00811727017024 60-ME0220-100 60-ME0220-100 Pointe Methadone Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Methadone Pointe Methadone Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Methadone Reagent Set is intended for the qualitative and semi-quantitative determination of methadone in human urine at a cutoff value of 300 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. DJR Enzyme Immunoassay, Methadone 2 Pointe Methadone Reagent Set
36 00811727013743 13-A7516-R2-30 13-A7516-R2-30 For the quantitative determination of Alanine Aminotransferase in serum. CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes 2 Alk Phos R2 (w/ssa#)
37 00811727013736 13-A7516-R2-125 13-A7516-R2-125 For the quantitative determination of alkaline phosphatase in human serum. For For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes 2 Alk Phos R2 (w/ssa#)
38 00811727013705 13-A7502-STD 13-A7502-STD Intended for use as an albumin standard for standardization or calibration of br Intended for use as an albumin standard for standardization or calibration of bromocresol green (BCG) dye-binding albumin procedures. CIX Bromcresol Green Dye-Binding, Albumin 2 Albumin Std (w/ssa#)
39 00811727013699 13-A7502-500 13-A7502-500 For the quantitative determination of Albumin in serum. CIX Bromcresol Green Dye-Binding, Albumin 2 Albumin (w/ssa#)
40 00811727013682 13-A7502-120 13-A7502-120 For the quantitative determination of Albumin in serum. CIX Bromcresol Green Dye-Binding, Albumin 2 Albumin (w/ssa#)
41 00811727013668 12-T7532-160 12-T7532-160 For the in vitro quantitative determination of Triglycerides in serum or plasma. CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides 1 Triglyceride
42 00811727013644 12-P7516-160 12-P7516-160 For the quantitative determination of Inorganic Phosphorus in serum. 4 x 40 ml CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus 1 Phosphorus
43 00811727016768 60-HY0776-5 60-HY0776-5 Pointe Hydrocodone 100 Level 2 Control (125 ng/mL) 1 x 5 mL The Pointe Hydrocodo Pointe Hydrocodone 100 Level 2 Control (125 ng/mL) 1 x 5 mL The Pointe Hydrocodone 100 Controls are for use as assayed quality control materials to monitor the precision of the Pointe Hydrocodone 100 Reagent Set (Ref# 60-HY0760-100/60-HY0760-1L) on a number of automated clinical chemistry analyzers. LAS Drug Specific Control Materials 1 Pointe Hydrocodone 100 Level 2 Control (125 ng/mL)
44 00811727013583 12-HB979-192 12-HB979-192 For the quantitative determination of total bilirubin in serum on Hitachi analyz For the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only. CIG Diazo Colorimetry, Bilirubin 2 Total Bilirubin
45 00811727013576 12-HB936-156 12-HB936-156 For the quantitative determination of direct bilirubin in serum on Hitachi analy For the quantitative determination of direct bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only. CIG Diazo Colorimetry, Bilirubin 2 Direct Bilirubin
46 00811727013439 12-B7552-150 12-B7552-150 For the quantitative determination of urea nitrogen in serum. For in vitro diag For the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen 2 POINTE SCIENTIFIC BUN
47 00811727016973 60-OP0666-5 60-OP0666-5 Pointe Opiates 2000 Calibrator (Morphine 2000 ng/mL) 1 x 5 mL The Pointe Opiates Pointe Opiates 2000 Calibrator (Morphine 2000 ng/mL) 1 x 5 mL The Pointe Opiates 2000 Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Opiates 2000 Reagent Set (Ref# 60-OP0660-100/60-OP0660-1L) on a number of automated clinical chemistry analyzers. DLJ Calibrators, Drug Specific 2 Pointe Opiates 2000 Calibrator (Morphine 2000 ng/mL)
48 00811727013064 HL956-295 HL956-295 LD Reagent is for the quantitative kinetic determination of lactate dehydrogenas LD Reagent is for the quantitative kinetic determination of lactate dehydrogenase activity in serum on Hitachi analyzers. For in vitro diagnostic use only.5 x 42ml, 5 x 17ml. CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase 2 Pointe Scientific, Inc. LD
49 00811727018373 60-MP0716-5 60-MP0716-5 Pointe Methamphetamine Control (625 ng/mL) Level 2 1 x 5 mL The Pointe Methamphe Pointe Methamphetamine Control (625 ng/mL) Level 2 1 x 5 mL The Pointe Methamphetamine Controls are for use as assayed quality control materials to monitor the precision of the Pointe Methamphetamine Reagent Set (Ref# 60-MP0700-100/60-MP0700-1L) on number of automated clinical chemistry analyzers. LAS Drug Specific Control Materials 1 Pointe Methamphetamine Control (625 ng/mL) Level 2
50 00811727018120 60-MM0410-5 60-MM0410-5 Pointe Methadone Metabolite (EDDP) Calibrator (500 ng/mL) High 1 x 5 mL The Poin Pointe Methadone Metabolite (EDDP) Calibrator (500 ng/mL) High 1 x 5 mL The Pointe Methadone Metabolite (EDDP) 100 Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Methadone Metabolite (EDDP) Reagent Set (Ref# 60-MM0380-100/60-MM0380-1L) at the cutoff value of 100 ng/mL on automated clinical chemistry analyzers. DLJ Calibrators, Drug Specific 2 Pointe Methadone Metabolite (EDDP) Calibrator (500 ng/mL) High
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1 00386100002053 10209-4 10209-4 Carbon dioxide Reagent Kit for use with EasyRA Analyzers CO2 Reagent Kit MEDICA CORPORATION
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18 05055273213959 CD8357 CD8357 The device is intended for the quantitative in vitro determination of carbon dio The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma. LCO2-2 RANDOX LABORATORIES LIMITED
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20 05055273201086 CD7942 CD7942 The device is intended for the quantitative in vitro determination of carbon dio The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma. CO2 RANDOX LABORATORIES LIMITED
21 05055273201031 CD129 CD129 The device is intended for the quantitative in vitro determination of carbon dio The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma. CO2 RANDOX LABORATORIES LIMITED
22 05055273201024 CD127 CD127 The device is intended for the quantitative in vitro determination of carbon dio The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma. CO2 RANDOX LABORATORIES LIMITED
23 05055273201017 CD116 CD116 The device is intended for the quantitative in vitro determination of carbon dio The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma. CO2 RANDOX LABORATORIES LIMITED
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32 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.
33 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.
34 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.
35 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.
36 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.
37 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.
38 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.
39 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.
40 00857969006150 SA2039 SA2039 Carbon Dioxide Reagent ACE ALFA WASSERMANN, INC.
41 00852169008072 CAR1090 CAR1090 In Vitro Diagnostics testing kit R1:6X30mL ClearChem Diagnostics Inc. Carbon Dioxide (CO2) CLEARCHEM DIAGNOSTICS INC.
42 00845275000047 TR28321 Thermo Scientific Infinity™ FISHER DIAGNOSTICS
43 00842768015625 10445163 K1137 Carbon Dioxide Flex® reagent cartridge, 3360 Tests Dimension Vista® Flex® reagent cartridge CO2 SIEMENS HEALTHCARE DIAGNOSTICS INC.
44 00842768005374 10444972 DF137 Enzymatic Carbonate Flex® reagent cartridge, 360 tests Dimension® Flex® reagent cartridge EC02 SIEMENS HEALTHCARE DIAGNOSTICS INC.
45 00817302022988 DT313 DT313 CO2 (Carbon Dioxide) 4 x 300 tests CAROLINA LIQUID CHEMISTRIES CORP.® CO2 REAGENT PRODUCT NO. DT313 CAROLINA LIQUID CHEMISTRIES CORPORATION
46 00817302022049 AU-313 AU-313 CO2 (Carbon Dioxide) w/ cal 3 x 250 tests CAROLINA LIQUID CHEMISTRIES CORP.® CO2 RGT. KIT AU-313 CAROLINA LIQUID CHEMISTRIES CORPORATION
47 00817302022032 ST313 ST313 CO2 (Carbon Dioxide) w/ cal 4 x 200 tests CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 CO2 RGT KIT Product No. ST313 CAROLINA LIQUID CHEMISTRIES CORPORATION
48 00817302022025 BL313 BL313 CO2 (Carbon Dioxide) w/ cal 3 x 140 tests CAROLINA LIQUID CHEMISTRIES CORP.® CO2 RGT. KIT BL-313 CAROLINA LIQUID CHEMISTRIES CORPORATION
49 00817274022498 CO23-125 C023-125 CARBON DIOXIDE LIQUID 405nm (2x 125mL) JAS Diagnostics DREW SCIENTIFIC, INC.
50 00817274021118 XL-CO23-20 CARBON DIOXIDE LIQUID 405nm (6x 20mL) JAS Diagnostics DREW SCIENTIFIC, INC.