Other products from "CLINICAL DIAGNOSTIC SOLUTIONS, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 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. LCP Assay, Glycosylated Hemoglobin HbA1c Reagent Set
2 00812137012067 R1 x 2 x 70mL, R2 x 1 x 50mL 501-419 The HDL-Cholesterol Reagent Set is intended for the in vitro quantitative determ The HDL-Cholesterol Reagent Set is intended for the in vitro quantitative determination of High Density Lipoprotein Cholesterol in human serum or plasma. The reagent can assist in the diagnosis and treatment of patients at risk for developing coronary heart disease. LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl HDL Cholesterol Reagent Set
3 00812137012050 500mL 501-418 For the quantitative determination of Uric Acid in serum. For in vitro diagnost For the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only. The determination of uric acid in serum is most commonly performed for the diagnosis of gout. Increased uric acid levels are also found in leukemia, polycythemia, familial idiopathic hyperuricemia, and conditions associated with decreased renal function. KNK Acid, Uric, Uricase (Colorimetric) 1 Uric Acid Reagent
4 00812137011916 R1 x 500mL, R2 x 125mL 501-404 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. Determination of urea nitrogen in serum is widely used as a screening test for renal function. When used in conjunction with the determination of creatinine in serum it is helpful in the differential diagnosis of the three types of azotemia; pre-renal, renal and post-renal. CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen Urea Nitrogen Reagent Set
5 00812137012111 10 x 5mL, 1 x 50mL 502-151 The Chemistry calibrator is for use as a calibrator of CDS clinical chemistry as The Chemistry calibrator is for use as a calibrator of CDS clinical chemistry assays. This calibrator material is well suited for automated and semi-automated analytical procedures. The Chemistry calibrator is a human based serum. The concentration of the calibrator components have been adjusted to ensure optimal calibration of the CDS methods on specified analyzers. The product consists of lyophilized human serum and a diluent for reconstitution. The human serum contains additives to provide the defined assay values. The concentrations of the calibrator components are lot-specific. JIX Calibrator, Multi-Analyte Mixture Chemistry Calibrator Set
6 00812137012005 R1 x 500mL, R2 x 125mL 501-413 For the in vitro quantitative kinetic determination of lactate dehydrogenase act For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. Increased levels of LD are associated with myocardial infarction. Levels reach a maximum approximately 48 hours after the onset of pain and persist about ten days. The degree of elevation is of value in assessing the extent of damage and in developing a prognosis. LD elevations are also observed in liver disease, pernicious anemia, in some cases of renal disease, and in some cases of skeletal muscle trauma. CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase LDH Reagent Set
7 00812137011909 R1 x 500mL, R2 x 15mL 501-403 For the quantitative determination of total bilirubin in serum. CIG Diazo Colorimetry, Bilirubin Total Bilirubin Reagent Set
8 00812137010254 6 x 16 mL 502-006 CDS-LTX Control is used to validate volume, conductivity and light scatter param CDS-LTX Control is used to validate volume, conductivity and light scatter parameters on COULTER HmX/ MAXM, STKS and GEN-S instruments. Prepare instrument with CDS LTX Primer immediately prior to CDS-LTX Control measurements.Accurate differential and reticulocyte measurements on COULTER HmX/MAXM, STKS and GEN-S instruments are assured by demonstrating consistent performance of volume, conductivity and light scatter parameters, using a particle of uniform size with appropriate light scattering characteristics. CDS-LTX Control validates the stability of the electrical processing and fluidic flow rate systems used to measure volume, conductivity and light scatter. KRX Calibrator For Cell Indices CDS-LTX CONTROL
9 00001812701208 500mL 501-417 For the in vitro quantitative determination of Triglycerides in serum or plasma. For the in vitro quantitative determination of Triglycerides in serum or plasma. Triglycerides determinations are of interest in the diagnosis and treatment of atherosclerosis, poorly controlled diabetes mellitus, nephrosis, liver disease, or other diseases involving lipid metabolism. CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides 1 Triglycerides Reagent
10 00812137012173 2 x 2mL 502-157 For calibrating the quantitative Direct Total Iron-Binding Capacity (TIBC) assay For calibrating the quantitative Direct Total Iron-Binding Capacity (TIBC) assay on automated chemistry analyzer systems. Using the Direct TIBC reagents, measurement of the total iron-binding capacity of serum occurs in a fully automated manner, without the need for any off-line separation. Since the entire reaction process is monitored by the chemistry analyzer, it is necessary to calibrate the assay with serum-based calibrators which are carried through the same reaction process as the patient specimens. JIT Calibrator, Secondary TIBC Calibrator Set
11 00812137012036 500mL 501-416 For the quantitative determination of total protein concentration in serum. CEK Biuret (Colorimetric), Total Protein 2 Total Protein Reagent
12 00812137011862 R1 x 500mL, R2 x 125mL 501-399 For the quantitative determination of Alanine Aminotransferase in serum. ALT is For the quantitative determination of Alanine Aminotransferase in serum. ALT is widely distributed in tissues with the highest concentrations found in the liver and kidneys. Even so, ALT is considered more liver-specific than AST. Elevated levels of ALT are often only observed in liver diseases such as cirrhosis, hepatitis, or metastatic carcinoma. However, there can be elevated levels of ALT with infectious mononucleosis, muscular dystrophy, and dermatomyositis. CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt ALT (SGPT) Reagent Set
13 00812137010247 Tri-Pack 6x3.0mL 502-004 For in vitro diagnostic use as a control to monitor the performance of multi-par For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. CDS 3PD Hematology Control is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific CDS reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product and should be considered a suggested average until you establish your own running mean. JPK Mixture, Hematology Quality Control CDS™ 3-PD Hematology Control
14 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. LCP Assay, Glycosylated Hemoglobin HbA1c Control Set
15 00812137011299 12 x 4.5mL 501-608 For in vitro diagnostic use as a control to monitor the performance of multi- pa For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff Hematology Control is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific Boule reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product. JPK Mixture, Hematology Quality Control Boule Con-Diff Tri-Level
16 00812137010230 9 x 4.5mL 501-607 For in vitro diagnostic use as a control to monitor the performance of multi- pa For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff Hematology Control is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific Boule reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product. JPK Mixture, Hematology Quality Control Boule Con-Diff Tri-Level
17 00812137010216 6 x 4.5mL 501-605 For in vitro diagnostic use as a control to monitor the performance of multi- pa For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff Tri-Level is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific Boule reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product. JPK Mixture, Hematology Quality Control Boule Con-Diff Tri-Level
18 00812137012135 10 x 5mL 502-153 The Chemistry Control Level II is to be used for monitoring the accuracy and pre The Chemistry Control Level II is to be used for monitoring the accuracy and precision of clinical chemistry procedures. This control contains constituents commonly of interest in a general chemistry control, including common drugs and thyroids. For in vitro diagnostic use only. The quality control material is prepared from human serum with enzymes, nonprotein constituents, non-human protein, and bacteriostatic agents added. The constituents were adjusted to the levels listed in Expected Values. JJY Multi-Analyte Controls, All Kinds (Assayed) Chemistry Control Level II Set
19 00812137011992 R1 x 500mL, R2 x 15mL 501-412 For the quantitative determination of iron in serum. For in vitro diagnostic use only. JIY Photometric Method, Iron (Non-Heme) Iron Reagent Set
20 00812137011954 R1 x 120mL, R2 x 30mL 501-408 For the quantitative determination of creatine kinase activity in serum. Serum c For the quantitative determination of creatine kinase activity in serum. Serum creatinine kinase (CK) levels have proven valuable in the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscular dystrophy.¹ Determination of creatine kinase and lactate dehydrogenase isoenzymes provides a definitive diagnosis of acute myocardial infarction. CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes CK-NAC Reagent Set
21 00812137011947 120mL 501-407 For the quantitative determination of Carbon Dioxide in serum. For in vitro dia For the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use only. KHS Enzymatic, Carbon-Dioxide 2 Carbon Dioxide Reagent
22 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. LCP Assay, Glycosylated Hemoglobin HbA1c Calibrator Set
23 00812137012197 L1 x 3mL, L2 x 3mL, L3 x 3mL 502-160 This product is intended for in-vitro use in the quality control of HDL, LDL, Ap This product is intended for in-vitro use in the quality control of HDL, LDL, Apolipoprotein A-1, Apolipoprotein B, and Lipopro-tein (a) methods on clinical chemistry systems. The Multi-Analyte Lipid Control Set is a set of three serum levels. These three levels are to be used exclusively with the CDS HDL Cholesterol Reagent, CDS LDL Cholesterol Reagent, (CDS 501-419 and CDS 501-420) which are assays for the quan-tification of various lipids and lipoproteins in human serum. JJY Multi-Analyte Controls, All Kinds (Assayed) Multi-Analyte Lipid Control Set
24 00812137012159 L1 x 3 x 3mL, L2 x 3 x 3mL 502-155 These CRP Controls Set are intended for use in CRP test systems to validate perf These CRP Controls Set are intended for use in CRP 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. C-reactive protein (CRP) is described in the literature as an acute phase protein that is involved in the activation of complement, acceleration of phagocytosis, and detoxification of substances released from damaged tissue. CRP is one of the most sensitive indicators of inflammation. DCK C-Reactive Protein, Antigen, Antiserum, And Control CRP Control Set
25 00812137012142 5 x 2mL 502-154 The CRP Calibrator Set is intended to be used for the calibration of the CDS CRP The CRP Calibrator Set is intended to be used for the calibration of the CDS CRP Reagents. For in vitro diagnostic use only. The calibrators in this kit contain known quantities of human C-reactive protein. These reagents are to be used as calibrators with the manufacturer’s CRP Reagents. DCK C-Reactive Protein, Antigen, Antiserum, And Control CRP Calibrator Set
26 00812137012074 R1 x 2 x 70mL, R2 x 1 x 50mL 501-420 The LDL-Cholesterol Reagent Set is intended for the in vitro quantitative determ The LDL-Cholesterol Reagent Set is intended for the in vitro quantitative determination of Low Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. Elevated LDL cholesterol is the primary target of cholesterol-lowering therapy. LBR Ldl & Vldl Precipitation, Hdl LDL Cholesterol Reagent Set
27 00812137011985 500mL 501-411 For the in vitro quantitative measurement of glucose in serum. The measurement For the in vitro quantitative measurement of glucose in serum. The measurement of glucose concentrations in biological fluids has been well documented. Glucose testing can be diagnostically significant in diabetes, hypoglycemia, and various adrenal and pituitary disorders. CFR Hexokinase, Glucose 2 Glucose Reagent
28 00812137011978 R1 x 500mL, R2 x 125mL 501-410 For the quantitative kinetic determination of gamma glutamyl transferase (GGT) a For the quantitative kinetic determination of gamma glutamyl transferase (GGT) activity in serum. GGT measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis, and primary and secondary tumors. Elevated GGT levels appear earlier and are more pronounced than those of other liver enzymes, in cases of obstructive jaundice and metastatic neoplasms. JQB Kinetic Method, Gamma-Glutamyl Transpeptidase GGT Reagent Set
29 00812137011893 R1 x 500mL, R2 x 15mL 501-402 For the quantitative determination of direct bilirubin in serum. CIG Diazo Colorimetry, Bilirubin Direct Bilirubin Reagent Set
30 00812137011930 500mL 501-406 For the quantitative determination of Total Cholesterol in serum. CHH Enzymatic Esterase--Oxidase, Cholesterol 1 Cholesterol Reagent
31 00812137011886 R1 x 500mL, R2 x 125mL 501-401 For the quantitative determination of Aspartate Aminotransferase (AST) in human For the quantitative determination of Aspartate Aminotransferase (AST) in human serum. AST is widely distributed in tissues with the highest concentrations found in the liver, heart, skeletal muscle and kidneys. Diseases involving any of these tissues can lead to elevated levels of AST in serum. Following myocardial infarction, AST levels are elevated and reach a peak after 48 to 60 hours.Hepatobiliary diseases such as cirrhosis, metastatic carcinoma and viral hepatitis can show increased levels of AST. Other disorders which can lead to an elevated level of AST are muscular dystrophy, dermatomyositis, acute pancreatitis and infectious mononucleosis. CIT Nadh Oxidation/Nad Reduction, Ast/Sgot AST (SGOT) Reagent Set
32 00812137011855 R1 x 500 mL, R2 x 125 mL 501-398 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. Serum alkaline phosphatase estimations are of interest in the diagnosis of two groups of conditions; hepatobiliary disease and bone disease associated with increased osteoblastic activity. CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes Alkaline Phosphatase Reagent Set
33 00812137011848 500 mL 501-397 For the quantitative determination of Albumin in serum. CIX Bromcresol Green Dye-Binding, Albumin 2 Albumin Reagent
34 00812137010223 1 x 3.0mL 501-606 Boule Cal Hematology Calibrator is manufactured for calibration multi-pa Boule Cal Hematology Calibrator is manufactured for calibration multi-parameter hematology analyzers.Multi-parameter hematology analyzers require regular calibration in order to produce accurate results on patient samples. Calibration can be accomplished by transferring information to the analyzer through fresh blood samples, which have been assayed by reference methods. A more direct and convenient approach is to use a calibrator material with System Specific Values (SSV) assigned. Boule Cal is such a material.Boule Cal is a stable suspension of red blood cells, white blood cells and platelets. Assigned values are derived from replicate analyses on whole blood calibrated hematology analyzers (see reference procedures). A user analyzes Boule Cal on their instrument and computes calibration factors by comparing recovered values and assigned values. These factors provide the basis for making adjustments to the instrument. KRZ Calibrator For Hemoglobin And Hematocrit Measurement 2 Boule Cal
35 00812137012098 R1 x 50mL, R2 x 50mL 501-435 For the quantitative determination of C-reactive protein in serum or plasma by l For the quantitative determination of C-reactive protein in serum or plasma by latex particle enhanced immunoturbidimetric assay. For in vitro diagnostic use only. C-reactive protein (CRP) is an acute phase protein that is involved in the activation of complement, acceleration of phagocytosis, and detoxification of substances released from damaged tissue. As such, CRP is considered to be one of the most sensitive indicators of inflammation. DCK C-Reactive Protein, Antigen, Antiserum, And Control CRP Reagent Set
36 00812137012012 R1 x 2 x 120mL, R2 x 2 x 120mL 501-414 For the quantitative determination of magnesium in serum. For in vitro diagnosti For the quantitative determination of magnesium in serum. For in vitro diagnostic use only. Magnesium in the body is found primarily in bone with some in soft tissue, blood cells, and serum. Decreased levels have been observed in cases of diabetes, alcoholism, diuretics, hyperthyroidism, hypothyroidism, malabsorption, hyperalimenation, myocardial infarction, congestive heart failure and liver cirrhosis. Increased serum magnesium levels have been found in renal failure, diabetic acidosis, Addison’s disease, and vitamin D intoxication. JGJ Photometric Method, Magnesium Magnesium Reagent Set
37 00812137011923 500mL 501-405 For the quantitative determination of Calcium in serum or heparinized plasma. In For the quantitative determination of Calcium in serum or heparinized plasma. Increased serum calcium may be observed in hyperparathyroidism, vitamin D intoxication, multiple myeloma and some neoplastic diseases of bone. Decreased serum calcium may be observed in hypoparathyroidism, vitamin D deficiency, steatorrhea, nephrosis, and nephritis. CIC Cresolphthalein Complexone, Calcium 2 Calcium Arsenazo III Reagent
38 00812137011879 4 x 120 mL 501-400 For the quantitative kinetic determination of amylase activity in human serum us For the quantitative kinetic determination of amylase activity in human serum using a manual or automated procedure. The determination of amylase activity in serum is most commonly performed for the diagnosis and treatment of diseases of the pancreas. CIJ Saccharogenic, Amylase AMYLASE (CNPG3) Reagent Set
39 00812137012104 R1 x 90mL, R2 x 60mL 501-444 For use in the determination of total iron-binding capacity in serum on automate For use in the determination of total iron-binding capacity in serum on automated chemistry analyzers. For in vitro diagnostic use only. Total iron-binding capacity (TIBC) is the measure of the ability of serum proteins, principally transferrin, to bind iron. It is the maximum concentration of iron that the serum proteins can bind.Together with the total serum iron concentration, the TIBC is used in the diagnosis and treatment of iron deficiency anemia, other disorders of iron metabolism, and chronic inflammatory disorders. As an index of nutritional status, Serum TIBC is increased in iron deficiency, and decreased in anemia that is due to chronic disease. JIY Photometric Method, Iron (Non-Heme) Direct TIBC Reagent Set
40 00812137012029 500mL 501-415 For the quantitative determination of Inorganic Phosphorus in serum. CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus 1 Phosphorus Reagent
41 00812137011961 R1 x 500mL, R2 x 125mL 501-409 For the quantitative determination of creatinine in serum. For in vitro diagnos For the quantitative determination of creatinine in serum. For in vitro diagnostic use only. Creatinine assays are most frequently performed to aid in the determination of renal function. CGX Alkaline Picrate, Colorimetry, Creatinine Creatinine Reagent Set
42 00812137010421 1 x 4.5mL 502-068 CDS Hematology Calibrator is manufactured for calibration of multi-parameter hem CDS Hematology Calibrator is manufactured for calibration of multi-parameter hematology analyzers for WBC, RBC, Hgb, MCV, Plt and MPV, as applicable to the analyzer system. Multi-parameter hematology analyzers require periodic calibration in order to produce accurate results on patient samples. Calibration may be accomplished by transferring calibration factors to the analyzer through fresh blood samples that have been assayed by reference methods. However, a more direct and convenient approach is to use a calibrator material such as CDS Hematology Calibrator, having system-specific assigned values, derived from a carefully calibrated analyzer or group of analyzers.CDS Hematology Calibrator assigned values are derived from replicate analyses on whole blood calibrated hematology analyzers (see reference procedures). Replicate analyses are performed on the user’s analyzer and calibration factors are computed by comparing recovered values and assigned values. The CDS Hematology Calibrator values are then divided by these determined factors to provide calibration settings for making adjustments to the instrument. Hct, MCH, MCHC, RDW and the WBC differential parameters do not require calibration. KRZ Calibrator For Hemoglobin And Hematocrit Measurement 2 CDS Hematology Calibrator
43 00812137010414 Tri-Pack 6x4.5 mL 502-066 For in vitro diagnostic use as a control to monitor the performance of multi-par For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. CDS 3PD Hematology Control is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific CDS reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product and should be considered a suggested average until you establish your own running mean. JPK Mixture, Hematology Quality Control CDS 3PD Hematology Control
44 00812137010360 1x3.0mL 502-040 CDS Hematology Calibrator is manufactured for calibration of multi-parameter hem CDS Hematology Calibrator is manufactured for calibration of multi-parameter hematology analyzers for WBC, RBC, Hgb, MCV, Plt and MPV, as applicable to the analyzer system. Multi-parameter hematology analyzers require periodic calibration in order to produce accurate results on patient samples. Calibration may be accomplished by transferring calibration factors to the analyzer through fresh blood samples that have been assayed by reference methods. However, a more direct and convenient approach is to use a calibrator material such as CDS Hematology Calibrator, having system-specific assigned values, derived from a carefully calibrated analyzer or group of analyzers.CDS Hematology Calibrator assigned values are derived from replicate analyses on whole blood calibrated hematology analyzers (see reference procedures). Replicate analyses are performed on the user’s analyzer and calibration factors are computed by comparing recovered values and assigned values. The CDS Hematology Calibrator values are then divided by these determined factors to provide calibration settings for making adjustments to the instrument. Hct, MCH, MCHC, RDW and the WBC differential parameters do not require calibration. KRZ Calibrator For Hemoglobin And Hematocrit Measurement 2 CDS Hematology Calibrator
45 00812137010261 6 x 16mL 502-007 CDS-LTX Primer is used to prepare the tubing and instrument components on the CO CDS-LTX Primer is used to prepare the tubing and instrument components on the COULTER HmX/MAXM, STKS and GEN-S instruments prior to analyzing CDS LTX Control.The Coulter HmX/MAXM, STKS and GEN-S instruments require a clean sample line prior to aspirating CDS LTX-Control. Otherwise, performance might be adversely affected through increased coefficients of variation for the volume, conductivity and light scatter parameters. KRY Calibrator For Platelet Counting CDS-LTX PRIMER
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22 08718734961499 Level 3 221.003.010 CueSee® VeriSTAT QC - Level 3 is an assayed aqueous quality control material for CueSee® VeriSTAT QC - Level 3 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. CueSee® VeriSTAT QC EUROTROL B.V.
23 08718734961482 Level 2 221.002.010 CueSee® VeriSTAT QC - Level 2 is an assayed aqueous quality control material for CueSee® VeriSTAT QC - Level 2 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. CueSee® VeriSTAT QC EUROTROL B.V.
24 08718734961475 Level 1 221.001.010 CueSee® VeriSTAT QC - Level 1 is an assayed aqueous quality control material for CueSee® VeriSTAT QC - Level 1 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. CueSee® VeriSTAT QC EUROTROL B.V.
25 08718734961468 220.000.005 CueSee® VeriSTAT LVM is an assayed aqueous blood gas, electrolyte and metabolite CueSee® VeriSTAT LVM is an assayed aqueous blood gas, electrolyte and metabolite control material suitable for calibration verification of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT LVM should be used in the periodic verification of the precision and accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.A box of CueSee® VeriSTAT LVM contains 5 levels of control material:CueSee® VeriSTAT LVM Level 1 - 08718734961413CueSee® VeriSTAT LVM Level 2 - 08718734961420CueSee® VeriSTAT LVM Level 3 - 08718734961437CueSee® VeriSTAT LVM Level 4 - 08718734961444CueSee® VeriSTAT LVM Level 5 - 08718734961451 CueSee® VeriSTAT LVM EUROTROL B.V.
26 08718734960928 183.000.005 Product is packaged in Eurotrol boxes, containing 5 ampules, one ampule of each Product is packaged in Eurotrol boxes, containing 5 ampules, one ampule of each level.It is a convenience kit for the purposes of UDI compliance because it contains 5 different levels that are packaged together for the convenience of the user and intended to remain packaged together and not replaced, substituted, repackaged, sterilized or otherwise processed or modified before being used by an end user. Therefore, the label of each individual vial within the container is not required to bear a UDI,provided that a UDI is available on the label affixed to the immediate container of the kit. Eurotrol EUROTROL B.V.
27 08718734960911 179.003.010 Eurotrol EUROTROL B.V.
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30 08718734960805 267.000.005 267.000.005 Eurotrol® epoc® Calibration Verification Fluids is a single use, assayed blood g Eurotrol® epoc® Calibration Verification Fluids is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol® epoc® Calibration Verification Fluids is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2. Eurotrol® epoc® Calibration Verification Fluids EUROTROL B.V.
31 08718734960799 Level 6 266.006.010 Eurotrol epoc® GAS-ISE Metabolites - Level 6 is a single use, assayed blood gas, Eurotrol epoc® GAS-ISE Metabolites - Level 6 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 6 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2. Eurotrol epoc GAS-ISE Metabolites EUROTROL B.V.
32 08718734960775 Level 3 266.003.010 Eurotrol epoc® GAS-ISE Metabolites - Level 3 is a single use, assayed blood gas, Eurotrol epoc® GAS-ISE Metabolites - Level 3 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 3 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2. Eurotrol epoc GAS-ISE Metabolites EUROTROL B.V.
33 08718734960751 Level 2 266.002.010 Eurotrol epoc® GAS-ISE Metabolites - Level 2 is a single use, assayed blood gas, Eurotrol epoc® GAS-ISE Metabolites - Level 2 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 2 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2. Eurotrol epoc GAS-ISE Metabolites EUROTROL B.V.
34 08718734960737 Level 1 266.001.010 Eurotrol epoc® GAS-ISE Metabolites - Level 1 is a single use, assayed blood gas, Eurotrol epoc® GAS-ISE Metabolites - Level 1 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 1 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2. Eurotrol epoc GAS-ISE Metabolites EUROTROL B.V.
35 08430793040587 724122 The Celiac Disease IgA Controls include antibodies to tTG and DGP1. Aptiva Celia The Celiac Disease IgA Controls include antibodies to tTG and DGP1. Aptiva Celiac IgA Control 1: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers and preservatives.2. Aptiva Celiac IgA Control 2: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers, and preservatives. Aptiva® Celiac Disease IgA Controls INOVA DIAGNOSTICS, INC.
36 08430793040525 724102 The Celiac Disease IgG Controls include antibodies to tTG and DGP.1. Aptiva Celi The Celiac Disease IgG Controls include antibodies to tTG and DGP.1. Aptiva Celiac IgG Control 1: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers and preservatives.2. Aptiva Celiac IgG Control 2: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers, and preservatives. Aptiva® Celiac Disease IgG Controls INOVA DIAGNOSTICS, INC.
37 08426951346479 0003310350 00003310350 Avox-4 CO-Oximeter Control Level 1, Level 2 and Level 3 Avox-4 CO-Oximeter Control INSTRUMENTATION LABORATORY COMPANY
38 08426951346462 0003310300 00003310300 Avox-4 CO-Oximeter Control, Level 3 Avox-4 CO-Oximeter Control - L3 INSTRUMENTATION LABORATORY COMPANY
39 08426951346455 0003310200 00003310200 Avox-4 CO-Oximeter Control, Level 2 Avox-4 CO-Oximeter Control - L2 INSTRUMENTATION LABORATORY COMPANY
40 08426951346448 0003310100 00003310100 Avox-4 CO-Oximeter Control, Level 1 Avox-4 CO-Oximeter Control - L1 INSTRUMENTATION LABORATORY COMPANY
41 08426951293810 00044000103 00044000103 ChemSTAT System Evaluator 3, 10 ampoules x 1.8 mL ChemSTAT System Evaluator 3 INSTRUMENTATION LABORATORY COMPANY
42 08426951293803 00044000102 00044000102 ChemSTAT System Evaluator 2, 10 ampoules x 1.8 mL ChemSTAT System Evaluator 2 INSTRUMENTATION LABORATORY COMPANY
43 08426951293797 00044000101 00044000101 ChemSTAT System Evaluator 1, 10 ampoules x 1.8 mL ChemSTAT System Evaluator 1 INSTRUMENTATION LABORATORY COMPANY
44 08426951293780 00044001515 00044001515 GEM ChemSTAT PVP1-5, 5 levels x 5 ampoules x 1.8 mL GEM ChemSTAT PVP 1-5 INSTRUMENTATION LABORATORY COMPANY
45 08426951293773 00044000140 00044000140 GEM ChemSTAT CVP 4, 10 ampoules x 1.8 mL GEM ChemSTAT CVP 4 INSTRUMENTATION LABORATORY COMPANY
46 08426951293766 00044000130 00044000130 GEM ChemSTAT CVP 3, 10 ampoules x 1.8 mL GEM ChemSTAT CVP 3 INSTRUMENTATION LABORATORY COMPANY
47 08426951293759 00044000125 00044000125 GEM ChemSTAT CVP 2, 10 ampoules x 1.8 mL GEM ChemSTAT CVP 2 INSTRUMENTATION LABORATORY COMPANY
48 08426951293742 00044000115 00044000115 GEM ChemSTAT CVP 1, 10 ampoules x 1.8 mL GEM ChemSTAT CVP 1 INSTRUMENTATION LABORATORY COMPANY
49 08426950573654 00025000103 00025000103 GEM System Evaluator 3 GEM System Evaluator 3 INSTRUMENTATION LABORATORY COMPANY
50 08426950573647 00025000102 00025000102 GEM System Evaluator 2 GEM System Evaluator 2 INSTRUMENTATION LABORATORY COMPANY