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Mission CliniCheck Controls is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the following analytes: Acetaminophen, Acid Phosphatase (Total), Alanine Aminotransferase (ALT/GPT), Albumin, Alkaline Phosphatase (ALP), Alpha-1 Anti-Trypsin, Alpha Fetoprotein, Alpha Hydroxybutyrate Dehydrogenase (α-HBDH), Amylase, Apolipoprotein A-1 (APO-A1), Aspartate Aminotransferase (AST/GOT), Bilirubin (Direct), Bilirubin (Total), C3 Complement, C4 Complement, Calcium, Carbon Dioxide (CO2), Carcinoembryonic Antigen (CEA), Ceruloplasmin, Chloride, Cholesterol (Total), HDL- Cholesterol, LDL-Cholesterol, Cholinesterase, Creatine Kinase (CK), Creatinine, Digoxin, Gamma Glutamyltransferase (GGT), Glucose, Haptoglobin, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Iron, Iron-Binding Capacity, Total (TIBC), Iron-Binding Capacity, Unsaturated (UIBC), Lactate (Lactic acid), Lactate Dehydrogenase (LDH), Lipase, Lithium, Magnesium, Phosphorus, Potassium, Protein-Total, Salicylate, Sodium, T3 Free, T3 Total, T4 Free, T4 Total, Thyroid Stimulating Hormone (TSH), Transferrin, Triglycerides, Urea Nitrogen, and Uric Acid on instruments listed in the expected values chart.

Mission CliniCheck Assayed Chemistry Control is a human serum based product containing constituents of purified biochemicals (tissue extracts of human and animal origin), chemicals, therapeutic drugs, preservatives and stabilizers. Two levels of Control are provided in a lyophilized form. Each level is packaged into a glass amber bottle containing 5mL of product. The product is packaged in single level boxes (12 x 5mL) or multiple level boxes (6 x 2 x 5mL) and stored at 2 - 8°C.

The SMARTLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood, pre-diluted urine samples. In addition, the analyzer can also measure sodium, chloride and calcium in dialysate samples. The SMARTLYTE Sodium Assay is intended to measure sodium in whole blood, serum, plasma, pre-diluted urine and dialysate on the SMARTLYTE Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. The SMARTLYTE Potassium Assay is intended to measure potassium in whole blood, serum, plasma, urine and dialysate. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. The SMARTLYTE Chloride Assay is intended to measure the level of chloride in whole blood, serum, plasma, urine and dialysate. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. The SMARTLYTE Calcium Assay is intended to measure ionized calcium levels in whole blood, plasma, serum, and dialysate. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). The SMARTLYTE Lithium Assay is intended to measure lithium (from the drug lithium carbonate) in whole blood, plasma, and serum. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).

The SMARTLYTE Nat, K", CT, Ca*, Li Electrolyte Analyzer which can test serum, plasma, whole blood, pre-diluted urine samples, dialysate solutions and QC materials is identical to GEMLYTE Electrolyte Analyzer ( cleared under k082462) which tests serum, plasma, whole blood, pre-diluted urine samples, and QC materials. Both are microprocessor-controlled analyzers which utilize ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood, pre-diluted urine samples, dialysate solutions and QC materials. The analyzer self-calibrates using Diamond Diagnostics Fluid Pack (510(k) 013850) every 4 hours through out the day or on request. Sodium, potassium, chloride and calcium are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Lithium is a drug used to treat mental illness. Mission controls (510 (k) 033063) are the recommended . quality control material to be used daily.

The PROLYTE is intended to be a direct replacement for the PROLYTE Electrolyte Analyzer (K070104). The PROLYTE Electrolyte Analyzer is designed for clinical laboratory use by laboratory professionals to assess the levels of Sodium, Potassium, and Chloride found in whole blood, serum, plasma, and urine of patients. The analysis is performed in-vitro, and neither the analyzer nor any of its components come in contact with the patient. This analyzer is used by laboratory trained technicians in clinical laboratories to aid in the diagnosis and treatment of palients with electrolyte imbalance. These locations routinely conform to CLIA requlations, and conduct daily quality control programs. The PROLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, and chloride in whole blood, plasma, serum, and pre-diluted urine samples. The PROLYTE Sodium Assay is intended to measure sodium in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. The PROLYTE Potassium Assay is intended to measure potassium in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. The PROLYTE Chloride Assay is intended to measure the level of chloride in whole blood, plasma, serum, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. For In Vitro Diagnostic Use

The PROLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium and chloride in serum, plasma, whole blood and pre-diluted urine samples. The PROLYTE analyzer is designed with the user in mind. It is fully automated with simple 'Yes' or 'No' commands for menu navigation. This simple interface ensures that the analyzer be easy to use for quick analysis, (one minute for most samples), but also that the testing of samples can be done by even non-skilled operators with relative ease. The analyzer can be programmed to selfcalibrate using Mission Diagnostics Fluid Pack Na/K/Cl (510(k) 031159) at set intervals or on request. Sodium, potassium and chloride are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Mission Controls (510(k) 033063) are the recommended quality control material to be used daily.

Diamond Calibrators for Medica ISE Modules are intended for in-vitro diagnostics use to provide calibration points for the Na *, K , and Ci electrodes on the Poly-Chem and Randox Daytona instruments having the Medica ISE Module.

Diamond Calibrant A matrix consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in a foil bag with a draw tube and covered in a corrugated box. Each foil bag contains 500 ml of solution. Diamond Calibrant B matrix consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in a plastic bottle with a cap. Each plastic bottle contains 125 ml of solution.

Mission Trinity R TM Control is intended to be used as an assayed quality control material for monitoring the precision and performance of the following analytes pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, and lactate on blood gas, electrolyte, and metabolite analyzers as well as tHb, %O2Hb, %O2Sat, %COHb, %MetHb, %O2Ct & %HHb on CO-Oximeter instrumentation. It is for in vitro diagnostics use and for the quantitative determination of the analytes listed on the Expected Values Chart.

Trinity R matrix consists of a buffered solution of electrolytes, glucose, lactate, dyes and preservative. It is equilibrated with specific levels of CO2, O2, and N2. It contains no human or biological materials. Trinity R is provided in three (3) distinct levels of pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, %O2Hb, % HbO2Sat, %COHb, %MetHb, %O2Ct & %HHb covering the significant range of the instrument performance. It is packaged in sealed glass ampules, each containing 1.8 ml of solution. Ampules are packaged in single level boxes (30 ampules of same level) or tri-level boxes (10 ampules of each level).

The GemLyte is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in whole blood, plasma and serum, and prediluted urine samples. The GemLyte Potassium Assay is intended to measure potassium in whole blood, plasma, serum, and urine on the GemLyte Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. The GemLyte Sodium Assay is intended to measure sodium in whole blood, plasma, serum, and urine on the GemLyte Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. The GemLyte Chloride Assay is intended to measure the level of chloride in whole blood, plasma, serum, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. The GemLyte Calcium Assay is intended to measure the ionized calcium level in whole blood, plasma and serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). The GemLyte Lithium Assay is intended to measure lithium (from the drug lithium carbonate) in whole blood, plasma and serum. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).

The GemLyte is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood and prediluted urine samples. GemLyte analyzer is designed with the user in mind, it is fully automated with simple .Yes' or 'No' commands for menu navigation. This simple interface insures that not only will the analyzer be easy to use for quick analysis, (less than a minute for samples), but also that the testing of samples can be done by even non-skilled operators with relative ease. The analyzer self-calibrates using Diamond Diagnostics Fluid Pack (510(k) 013850) every 4 hours through out the day or on request. Sodium, potassium, chloride and calcium are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Lithium is a drug used to treat mental illness. Mission controls (510 (k) 033063) are the recommended quality control material to be used daily.

The proLYTE Electrolyte Analyzer is designed for clinical laboratory professionals to assess the levels of Sodium, Potassium, and Chloride found in whole blood, serum, plasma, and urine of patients. The analysis is performed in-vitro, and neither the analyzer nor any of its components come in contact with the patient. This analyzer is used by laboratory trained technicians in clinical laboratories to aid in the diagnosis and treatment of patients with electrolyte imbalance. These locations routinely conform to CLIA regulations, and conduct daily quality control programs. For In Vitro Diagnostic Use

The proLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium and chloride in serum, plasma, whole blood and prediluted urine samples, proLYTE analyzer is designed with the user in mind, it is fully automated with simple 'Yes' or 'No' commands for menu navigation. This simple interface insures that not only will the analyzer be easy to use for quick analysis, (one minute for most samples), but also that the testing of samples can be done by even non-skilled operators with relative ease. The analyzer an be programmed to self-calibrate using Mission Diagnostics ILyte 800 Fluid Pack Na/K/Cl (510(k) 031159) at set intervals or on request. Sodium, potassium and chloride are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Mission Controls (510(k) J33063) are the recommended quality control material to be used daily.

Mission Olympus AU ISE Calibrators are intended to provide calibration points for Na+, K+ and Cl- electrodes on the Olympus AU4xx and AU6xx instruments. For in-vitro diagnostics use.

Mission Olympus AU ISE Calibrators are intended to serve as a direct replacement to Olympus AU ISE Calibrators. They are aqueous solutions of salts & preservatives, containing NO human or animal materials, packaged in plastic bottles.

Mission Trinity B™ Controls are intended to be used as a quality control material for monitoring the performance of pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, %O2Hb, %COHb, %metHb & %HHb on Bayer instrumentation. For In Vitro Diagnostic Use

Trinity B is a specially formulated, three-level, aqueous material intended for use to monitor all analytes measured by the Bayer line of blood gas, electrolyte, metabolite and CO-Oximetry analyzers. Trinity B controls provide a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC as a part of their quality assurance program. Trinity B contains clinically relevant quantities of pH, PCO2, PO2, sodium, potassium, chloride, ionized calcium, glucose, lactate and suitable concentrations of dyes to simulate clinically relevant values of hemoglobin, and hemoglobin derivatives: O2Hb, COHb, MetHb and HHB.