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
Other products with the same Product Code "LCP"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00817643020223 34265 34265 A1CNow+ and 20-Test Kit Hopkins Medical Products® HOPKINS UNIFORM COMPANY
2 00817302022179 7-H7541-CAL 7-H7541-CAL HbA1c (Hemoglobin A1c) calibrator CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c CAL SET PART# 7-H7541-CAL CAROLINA LIQUID CHEMISTRIES CORPORATION
3 00817302022162 7-H7541-CTL 7-H7541-CTL HbA1c (Hemoglobin A1c) control CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c CTL SET PART# 7-H7541-CTL CAROLINA LIQUID CHEMISTRIES CORPORATION
4 00817302022155 BL300 BL300 HbA1c (Hemoglobin A1c Direct) 2 x 100 tests CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c RGT. KIT BL-300 CAROLINA LIQUID CHEMISTRIES CORPORATION
5 00817302022148 ST300 ST300 HbA1c 2 x 150 tests CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 HbA1c RGT KIT Pt No. ST300 CAROLINA LIQUID CHEMISTRIES CORPORATION
6 00817302022131 CC612 CC612 FRUC (Fructosamine) w/ cal 2 x 40 tests CAROLINA LIQUID CHEMISTRIES CORP.™ FRUC FRUCTOSAMINE CC612 CAROLINA LIQUID CHEMISTRIES CORPORATION
7 00817302022124 AU-612 AU-612 FRUC (Fructosamine) w/ cal 3 x 80 tests CAROLINA LIQUID CHEMISTRIES CORP.® FRUC RGT. KIT AU-612 CAROLINA LIQUID CHEMISTRIES CORPORATION
8 00817302022117 CC030 CC030 FRUC (Fructosamine) Control CAROLINA LIQUID CHEMISTRIES CORP.® FRUC CONTROL SET CC030 CAROLINA LIQUID CHEMISTRIES CORPORATION
9 00817302020083 CC300 CC300 HbA1c (Hemoglobin A1c) w/ lysis buffer 2 x 90 tests CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c REAGENT CC300 CAROLINA LIQUID CHEMISTRIES CORPORATION
10 00817302020076 AU-300 AU-300 HbA1c (Hemoglobin A1c Direct) 1 x 200 tests CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c RGT. KIT AU-300 CAROLINA LIQUID CHEMISTRIES CORPORATION
11 00817274021774 XL-A1C2-30 HEMOGLOBIN A1C REAGENT, (2x 30mL R1, 2x 9.5mL R2a, 2x 0.5mL R2b) JAS Diagnostics DREW SCIENTIFIC, INC.
12 00817274021767 A1C2-30 HEMOGLOBIN A1C REAGENT, (2x 30mL R1, 2x 9.5mL R2a, 2x 0.5mL R2b) JAS Diagnostics DREW SCIENTIFIC, INC.
13 00817274021750 A1C2-30A HEMOGLOBIN A1C REAGENT (1x 30mL R1, 1x 9.5mL R2a, 1x 0.5mL R2b JAS Diagnostics DREW SCIENTIFIC, INC.
14 00817274020593 014-081 Gold Column Kit Drew Scientific DREW SCIENTIFIC, INC.
15 00817274020524 DSJ-9001-021 DS360 HbA1c Analyzer (Instrument only) Drew DREW SCIENTIFIC, INC.
16 00817274020517 DSJ-9001-001 DS360 HbA1c Analyzer with accessories Drew Scientific DREW SCIENTIFIC, INC.
17 00817274020241 099-024 DS360 Column (1,000-Test) Drew DREW SCIENTIFIC, INC.
18 00817274020234 099-023 DS360 Reagent Test Kit (500 tests) Drew Scientific DREW SCIENTIFIC, INC.
19 00817274020173 014-350 DS5 Pink Kit (300 test) Drew Scientific DREW SCIENTIFIC, INC.
20 00817274020135 014-080 Gold Kit 80-100 Test Drew Scientific DREW SCIENTIFIC, INC.
21 00817238011322 85621 Hemoglobin A1C Reagent Hemoglobin A1C Reagent CLINIQA CORPORATION
22 00816426020788 K29C-4M K29C-4M For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for hemoglobin A1c. K-ASSAY® Hemoglobin A1c Control KAMIYA BIOMEDICAL COMPANY, LLC
23 00816426020696 KAI-098C KAI-098C For the calibration of the K-ASSAY® Hemoglobin A1c assay. K-ASSAY® Hemoglobin A1c Calibrator KAMIYA BIOMEDICAL COMPANY, LLC
24 00816426020597 KAI-048C KAI-048C For the calibration of the K-ASSAY® Fructosamine assay. K-ASSAY® Fructosamine Calibrator KAMIYA BIOMEDICAL COMPANY, LLC
25 00816426020528 KAI-197 KAI-197 For the quantitative determination of human hemoglobin A1c (HbA1c) in whole blood. K-ASSAY® Hemoglobin A1c Reagent (L) KAMIYA BIOMEDICAL COMPANY, LLC
26 00816426020511 KAI-196 KAI-196 For the quantitative determination of human hemoglobin A1c (HbA1c) in whole blood. K-ASSAY® Hemoglobin A1c Reagent KAMIYA BIOMEDICAL COMPANY, LLC
27 00816426020504 KAI-195 KAI-195 Hemolysis reagent for hemoglobin A1c (HbA1c) measurement. K-ASSAY® Hemoglobin A1c Hemolysis Reagent KAMIYA BIOMEDICAL COMPANY, LLC
28 00816426020269 KAI-050 KAI-050 For the quantitative determination of fructosamine in serum. K-ASSAY® Fructosamine Reagent + Calibrator (L) KAMIYA BIOMEDICAL COMPANY, LLC
29 00816426020238 KAI-043 KAI-043 For the quantitative determination of fructosamine in serum. K-ASSAY® Fructosamine Reagent + Calibrator KAMIYA BIOMEDICAL COMPANY, LLC
30 00812137012203 4 x 0.5mL 502-189 This product is for the purpose of calibrating results in the quantitative deter This product is for the purpose of calibrating results in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only. HbA1c Calibrator Set CLINICAL DIAGNOSTIC SOLUTIONS, INC.
31 00812137012166 L1 x 2 x 0.5mL, L2 x 2 x 0.5mL 502-156 This product is for the purpose of monitoring accuracy and precision in the quan This product is for the purpose of monitoring accuracy and precision in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only. Throughout the circulatory life of the red cell, Hemoglobin A1c is formed continuously by the adduction of glucose to the N-terminal of the hemoglobin beta chain. This process, which is non-enzymatic, reflects the average exposure of hemoglobin to glucose over an extended period. HbA1c Control Set CLINICAL DIAGNOSTIC SOLUTIONS, INC.
32 00812137012081 R1 x 30mL, R2 x 10mL, R3 x 125mL 501-421 For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. Th For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. HbA1c Reagent Set CLINICAL DIAGNOSTIC SOLUTIONS, INC.
33 00811727016164 16-H7546-200 16-H7546-200 Pointe HbA1c Reagent packaged for use on the Mindray BA800. 10 x 15ml R1, 5 x 1 Pointe HbA1c Reagent packaged for use on the Mindray BA800. 10 x 15ml R1, 5 x 10ml R2. For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. Pointe HbA1c Reagent POINTE SCIENTIFIC, INC.
34 00811727015853 14-H7546-160 14-H7546-160 Pointe HbA1c Reagent packaged for use on the BS480. 2x60mL, 2x20mL Kit. For the Pointe HbA1c Reagent packaged for use on the BS480. 2x60mL, 2x20mL Kit. For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. Pointe HbA1c for the BS480 POINTE SCIENTIFIC, INC.
35 00811727015044 OH546-40 OH546-40 Pointe Scientific, Inc. HbA1c Reagent is for the quantitative determination of H Pointe Scientific, Inc. HbA1c Reagent is for the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. Packaged for use on Olympus Analyzers. For in vitro diagnostic use only. 2 x 15ml, 1 x 10ml Pointe Scientific, Inc. HbA1c POINTE SCIENTIFIC, INC.
36 00811727014559 H7546-CAL H7546-CAL Liquid Hemoglobin A1c Calibrator Set, This product is for the purpose of calibra Liquid Hemoglobin A1c Calibrator Set, This product is for the purpose of calibrating results in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only. Size: 4 x 1 mL Pointe Scientific, Inc. POINTE SCIENTIFIC, INC.
37 00811727014542 H7546-120 H7546-120 Hemoglobin A1c Reagent, for the quantitative determination of Hemoglobin A1c (Hb Hemoglobin A1c Reagent, for the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. Size: 1 x 90 mL, 1 x 30 mL Pointe Scientific, Inc. POINTE SCIENTIFIC, INC.
38 00811727014535 H7546-40 H7546-40 Hemoglobin A1c Reagent, for the quantitative determination of Hemoglobin A1c (Hb Hemoglobin A1c Reagent, for the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. Size: 1 x 30 mL, 1 x 10 mL. Pointe Scientific, Inc. POINTE SCIENTIFIC, INC.
39 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 Pointe Scientific, Inc. Glyco Standard POINTE SCIENTIFIC, INC.
40 00811727014238 13-G7540-RES-120 13-G7540-RES-120 Reagent for the quantitative determination of Glycohemoglobin (HbA1) in blood by Reagent for the quantitative determination of Glycohemoglobin (HbA1) in blood by cation exchange resin. The test is to be used to monitor long-term glucose control in diabetes mellitus.1 x 120 ml Pointe Scientific, Inc. Glyco Resin POINTE SCIENTIFIC, INC.
41 00811727014221 13-G7540-LYS-30 13-G7540-LYS-30 Lyse for the quantitative determination of Glycohemoglobin (HbA1) in blood by ca Lyse for the quantitative determination of Glycohemoglobin (HbA1) in blood by cation exchange resin. The test is to be used to monitor long-term glucose control in diabetes mellitus.1 x 30 ml Pointe Scientific, Inc. Gyco Lyse POINTE SCIENTIFIC, INC.
42 00811727013569 12-H7546-40 12-H7546-40 For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. Th For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. HbA1c POINTE SCIENTIFIC, INC.
43 00811727013545 12-H7541-40 12-H7541-40 For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. Th For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. HbA1c POINTE SCIENTIFIC, INC.
44 00811727013521 12-F7546-55 12-F7546-55 This reagent is intended for the quantitative determination of fructosamine in h This reagent is intended for the quantitative determination of fructosamine in human serum. For in vitro diagnostic use only. Fructosamine POINTE SCIENTIFIC, INC.
45 00811727011541 H7541-CTL H7541-CTL This product is for the purpose of monitoring accuracy and precision in the quan This product is for the purpose of monitoring accuracy and precision in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only. 4 x 0.5ml Pointe Scientific, Inc. POINTE SCIENTIFIC, INC.
46 00811727011534 H7541-CAL H7541-CAL This product is for the purpose of calibrating results in the quantitative deter This product is for the purpose of calibrating results in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only. 4 x 0.5ml Pointe Scientific, Inc. POINTE SCIENTIFIC, INC.
47 00811727011510 H7541-120 H7541-120 Reagent for the quantitative determination of Hemoglobin A1c (HbA1c) in human bl Reagent for the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. 1 x 90ml, 1 x 28.5ml, 1 x 1.5ml Pointe Scientific, Inc. POINTE SCIENTIFIC, INC.
48 00811727011503 H7541-40 H7541-40 Reagent for the quantitative determination of Hemoglobin A1c (HbA1c) in human bl Reagent for the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. 1 x 30ml, 1 x 9.5ml, 1 x .5ml Pointe Scientific, Inc. POINTE SCIENTIFIC, INC.
49 00811727011336 G7540-2 G7540-2 Controls for use in the quantitative determination of human glycohemoglobin (HbA Controls for use in the quantitative determination of human glycohemoglobin (HbA1) in blood by cation exchange resin.2 x 1.0ml Pointe Scientific, Inc. POINTE SCIENTIFIC, INC.
50 00811727011329 G7540-STD 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 1.0ml Pointe Scientific, Inc. POINTE SCIENTIFIC, INC.