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 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
45 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
46 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)
47 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
48 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
49 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
50 00811727018113 60-MM0408-5 60-MM0408-5 Pointe Methadone Metabolite (EDDP) Calibrator (250 ng/mL) Intermediate 1 x 5 mL Pointe Methadone Metabolite (EDDP) Calibrator (250 ng/mL) Intermediate 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 (250 ng/mL) Intermediate
Other products with the same Product Code "CIG"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 03610230006887 1300023835 Yumizen C1200 Total Bilirubin HORIBA ABX SAS
2 03610230006870 1300023834 Yumizen C1200 Direct Bilirubin HORIBA ABX SAS
3 03610230005026 1220001639 ABX PENTRA BILIRUBIN, TOTAL CP HORIBA ABX SAS
4 03610230004982 1220001635 ABX PENTRA BILIRUBIN, DIRECT CP HORIBA ABX SAS
5 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.
6 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.
7 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.
8 EABA40000261 400-0026 400-0026 The Piccolo® Hepatic Function Panel, used with the Piccolo Xpress® chemistry ana The Piccolo® Hepatic Function Panel, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitroquantitative determinations of alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, directbilirubin, total bilirubin, and total protein in heparinized whole blood, heparinized plasma, or serum in a clinical laboratorysetting or point-of-care location. Piccolo Hepatic Function Panel ABAXIS, INC.
9 EABA40000031 400-0003 400-0003 The Piccolo® Liver Panel Plus, used with the Piccolo® blood chemistry analyzer o The Piccolo® Liver Panel Plus, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, utilizes dry and liquid reagents to provide in vitro quantitative determinations of alanine aminotransferase, albumin, alkaline phosphatase, amylase, aspartate aminotransferase, gamma glutamyltransferase, total bilirubin, and total protein 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 Liver Panel Plus ABAXIS, INC.
10 00857969006099 SA1008 SA1008 Total Bilirubin Reagent ACE ALFA WASSERMANN, INC.
11 00857969006082 SA1007 SA1007 Direct Bilirubin Reagent ACE ALFA WASSERMANN, INC.
12 00852169008102 BRB1060 BRB1060 In Vitro Diagnostics testing kit R1:3X42mL, R2:3X11mL ClearChem Diagnostics Inc. Bilirubin, Total CLEARCHEM DIAGNOSTICS INC.
13 00852169008096 BRD1050 BRD1050 In Vitro Diagnostics testing kit R1:3X28mL, R2:3X7mL ClearChem Diagnostics Inc. Bilirubin, Direct CLEARCHEM DIAGNOSTICS INC.
14 00851445007280 GEN-TBILI R3 GEN-TBILI R3 10/17/2022 GENCHEM™ Total Bilirubin Reagent GENCHEM INC
15 00851445007273 GEN-TBILI R2 GEN-TBILI R2 10/17/2022 GENCHEM™ Total Bilirubin Reagent GENCHEM INC
16 00851445007266 GEN-TBILI R1 GEN-TBILI R1 10/17/2022 GENCHEM™ Total Bilirubin Reagent GENCHEM INC
17 00851445007204 GEN-DBILI R2 GEN-DBILI R2 10/17/2022 GENCHEM™ Direct Bilirubin Reagent GENCHEM INC
18 00851445007198 GEN-DBILI R1 GEN-DBILI R1 10/17/2022 GENCHEM™ Direct Bilirubin Reagent GENCHEM INC
19 00845275002973 TR33321 Thermo Scientific FISHER DIAGNOSTICS
20 00845275001068 1245250 Thermo Scientific FISHER DIAGNOSTICS
21 00842768020551 10444956 DF125 Direct Bilirubin Flex® reagent cartridge, 320 tests Dimension® Flex® reagent cartridge DBI SIEMENS HEALTHCARE DIAGNOSTICS INC.
22 00842768020544 10444957 DF167 Total Bilirubin Flex® reagent cartridge, 480 tests Dimension® Flex® reagent cartridge TBI SIEMENS HEALTHCARE DIAGNOSTICS INC.
23 00842768015717 10445146 K1167 Total Bilirubin Flex® reagent cartridge, 640 Tests Dimension Vista® Flex® reagent cartridge TBIL SIEMENS HEALTHCARE DIAGNOSTICS INC.
24 00842768015649 10445152 K2125 Direct Bilirubin Flex® reagent cartridge, 480 tests Dimension Vista® Flex® reagent cartridge DBIL SIEMENS HEALTHCARE DIAGNOSTICS INC.
25 00842768014192 10444967 DF77 Uric Acid Flex® reagent cartridge, 480 tests Dimension® Flex® reagent cartridge URCA SIEMENS HEALTHCARE DIAGNOSTICS INC.
26 00842768005695 10444912 DF75A Thyronine Uptake Flex® reagent cartridge, 160 tests Dimension® Flex® reagent cartridge TU SIEMENS HEALTHCARE DIAGNOSTICS INC.
27 00842768005626 10444908 DF65 Thyroxine Flex® reagent cartridge, 120 tests Dimension® Flex® reagent cartridge T4 SIEMENS HEALTHCARE DIAGNOSTICS INC.
28 00842768004933 10459406 DC14 Thyronine Uptake Calibrator, 2x5x2mL Dimension® TU Calibrator SIEMENS HEALTHCARE DIAGNOSTICS INC.
29 00842768004919 10445029 DC13 Thyroxine Calibrator, 2x5x1mL, reconstituted Dimension® T4 Calibrator SIEMENS HEALTHCARE DIAGNOSTICS INC.
30 00817439021250 TIB600 TIB600 For the quantitative determination of total bilirubin in serum using the Mindray For the quantitative determination of total bilirubin in serum using the Mindray BS-200 analyzer. For in vitro diagnostic use only.3 x 40ml, 3 x 8ml. Total Bilirubin for the BS200 MEDTEST DX, INC.
31 00817439021243 TIB505 TIB505 For the quantitative determination of total bilirubin in serum using the Poly-Ch For the quantitative determination of total bilirubin in serum using the Poly-Chem 180 analyzer. For in vitro diagnostic use only. Total Bilirubin for the Polychem 180 MEDTEST DX, INC.
32 00817439021236 TIB480 TIB480 For the quantitative determination of total bilirubin in serum using the Mindray For the quantitative determination of total bilirubin in serum using the Mindray BS480 analyzer. For in vitro diagnostic use only.5 x 58ml, 5 x 15ml. MedTest DX Total Bilirubin for the BS480 MEDTEST DX, INC.
33 00817302023138 CC229 CC229 DBIL (Direct Bilirubin) 2 x 200 tests CAROLINA LIQUID CHEMISTRIES CORP.® DBIL DIRECT BILIRUBIN REAGENT CC230 CAROLINA LIQUID CHEMISTRIES CORPORATION
34 00817302023084 DT228 DT228 TBIL (Total Bilirubin) 4 x 300 tests CAROLINA LIQUID CHEMISTRIES CORP.® TBIL REAGENT PRODUCT NO. DT228 CAROLINA LIQUID CHEMISTRIES CORPORATION
35 00817302023053 DT229 DT229 DBIL (Direct Bilirubin) 4 x 300 tests CAROLINA LIQUID CHEMISTRIES CORP.® DBIL REAGENT PRODUCT NO. DT229 CAROLINA LIQUID CHEMISTRIES CORPORATION
36 00817302020717 CC228 CC228 TBIL (Total Bilirubin) 2 x 300 tests CAROLINA LIQUID CHEMISTRIES CORP.™ TBIL TOTAL BILIRUBIN REAGENT CC228 CAROLINA LIQUID CHEMISTRIES CORPORATION
37 00817302020700 AU-228 AU-228 TBIL (Total Bilirubin) 3 x 300 tests CAROLINA LIQUID CHEMISTRIES CORP.® TBIL RGT. KIT AU-228 CAROLINA LIQUID CHEMISTRIES CORPORATION
38 00817302020694 BL228 BL228 TBIL (Total Bilirubin) 3 x 100 tests CAROLINA LIQUID CHEMISTRIES CORP.® TBIL RGT. KIT BL-228 CAROLINA LIQUID CHEMISTRIES CORPORATION
39 00817302020687 ST228 ST228 TBIL (Total Bilirubin) 4 x 200 tests CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 TBIL RGT KIT Product No. ST228 CAROLINA LIQUID CHEMISTRIES CORPORATION
40 00817302020601 CC229 CC229 DBIL (Direct Bilirubin) 2 x 200 tests CAROLINA LIQUID CHEMISTRIES CORP.™ DBIL DIRECT BILIRUBIN REAGENT CC229 CAROLINA LIQUID CHEMISTRIES CORPORATION
41 00817302020595 AU-229 AU-229 DBIL (Direct Bilirubin) 3 x 200 tests CAROLINA LIQUID CHEMISTRIES CORP.® DBIL RGT. KIT Product No. AU-229 CAROLINA LIQUID CHEMISTRIES CORPORATION
42 00817302020588 BL229 BL229 DBIL (Direct Bilirubin) 3 x 100 tests CAROLINA LIQUID CHEMISTRIES CORP.® DBIL RGT. KIT Product No. BL-229 CAROLINA LIQUID CHEMISTRIES CORPORATION
43 00817302020571 ST229 ST229 DBIL (Direct Bilirubin) 4 x 150 tests CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 DBIL RGT KIT Product No. ST229 CAROLINA LIQUID CHEMISTRIES CORPORATION
44 00817274022528 TBN2-1L TBN2-1L TOTAL BILIRUBIN LIQUID (1 x 1L R1, 1 X 15 mL Sodium Nitrite) JAS Diagnostics DREW SCIENTIFIC, INC.
45 00817274022511 BID2-1L BID2-1L DIRECT BILIRUBIN LIQUID (1 x 1L R1, 1 x 15 mL Sodium Nitrite) JAS Diagnostics DREW SCIENTIFIC, INC.
46 00817274021989 XL-TBN2-40 TOTAL BILIRUBIN LIQUID (4x 40mL R1, 1x 5mL Sodium Nitrite) JAS Diagnostics DREW SCIENTIFIC, INC.
47 00817274021972 TBN2-BUL TOTAL BILIRUBIN BULK LIQUID JAS Diagnostics DREW SCIENTIFIC, INC.
48 00817274021965 TBN2-125U TOTAL BILIRUBIN (125mL) UV JAS Diagnostics DREW SCIENTIFIC, INC.
49 00817274021958 TBN2-125 TOTAL BILI LIQUID (2x 125mL R1, 1x 5mL Sodium Nitrite) JAS Diagnostics DREW SCIENTIFIC, INC.
50 00817274021941 DG-TBN2/BID2-125 TOTAL BILI LIQUID (1x 125mL), DIRECT BILIRUBIN (1x 125mL), 1x 5mL Sodium Nitrite. JAS Diagnostics DREW SCIENTIFIC, INC.