Search Results

The Linearity FD Tumor Markers II is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration, and the verification of reportable range for the following analytes: Alpha fetoprotein (AFP), Carcinoembryonic antigen (CEA), Prostate-specific antigen-total (PSA), Carbonic Anhydrase-125 (CA-125), Carbonic Anhydrase 19-9 (CA19-9), Carbonic Anhydrase 27-29 (CA27-29)(BR), free-PSA (fPSA), and Carbonic Anhydrase 15-3 (CA15-3). The Linearity FD Tumor Markers II is for In Vitro Diagnostic use only.

The Audit® MicroControls™ Linearity FD Tumor Markers II product is an in-vitro diagnostic device consisting of two sets of five levels of liquid, linearity/QC material. Set 1 contains the analytes: Alpha fetoprotein (AFP), Carcinoembryonic antigen (CEA), Prostate-specific antigentotal (PSA), Carbonic Anhydrase-125 (CA-125), Carbonic Anhydrase 19-9 (CA19-9), and Carbonic Anhydrase 27-29 (CA27-29) (BR) and additives in human serum. Set 2 contains the analytes: free-PSA (fPSA), and Carbonic Anhydrase 15-3 (CA15-3) and additives in human serum and bovine serum. For each set there are five levels labeled A, B, C, D and E. Both sets contain 1ml for each level. Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.

The Linearity FD Unsaturated Iron Binding Capacity is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration, and the verification of reportable range for unsaturated iron binding capacity. Linearity FD Unsaturated Iron Binding Capacity is for In Vitro Diagnostic use only.

Audit® MicroControls™ Linearity FD Unsaturated Iron Binding Capacity product is an in-vitro diagnostic device consisting of five levels of freeze dried, linearity/QC material, containing additives in human serum. There are five levels labeled A,B,C,D and E which contain 1ml for each level.

The Linearity LQ Special Diabetes is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration, and the verification of reportable range for the following analytes: fructosamine, insulin, and C-peptide. Linearity LQ Special Diabetes is for In Vitro Diagnostic use only.

The Audit® MicroControls™ Linearity LQ Special Diabetes product is an in-vitro diagnostic device consisting of five levels of liquid, linearity/QC material, containing Fructosamine, Insulin, C-peptide and additives in human serum. There are five levels labeled A, B, C, D and E which contain 2ml for each level. Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.

The Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set is an assayed quality control material consisting of five levels of human based serum. Each level contains: Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin. These five levels demonstrate a linear relationship to each other for their respective analytes. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification of reportable range for Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling and may be used as quality control material for these analytes. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set should not be used for calibration or standardization of the Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin assays. The Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set is "For In Vitro Diagnostic Use Only".

The Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set is an in-vitro diagnostic device consisting of five levels of Lyophilized linearity material containing Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin and additives in human serum. There are five vials labeled A, B, C, D, and E, and contain 5 mL for each level. Materials of human origin used in the manufacture of this linearity set has been tested using FDA approved methods and found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.

The Audit® MicroCV™ Vitamin D Linearity Set is an assayed quality control material consisting of five levels of human and equine based serum. Each level contains Vitamin D. These five levels demonstrate a linear relationship to each other for Vitamin D. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Vitamin D. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling and may be used as quality control material for Vitamin D. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit® MicroCV™ Vitamin D Linearity Set should not be used for calibration or standardization of the Vitamin D assay. The Audit® MicroCV™ Vitamin D Linearity Set is "For In Vitro Diagnostic Use Only".

The Audit® MicroCV™ Vitamin D Linearity Set is an assayed quality control material consisting of five levels of human and equine based serum, with each level containing Vitamin D. It is used to confirm the proper calibration, linear operating range, and reportable range of Vitamin D. Level A is near the lower limit level and Level E has concentrations near the upper limit of instruments. Levels B - D are related by linear dilution of Level A and Level E.

The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is an assayed quality control material consisting of five levels of human based serum. Each level contains Beta- Hydroxybutyric Acid. These five levels demonstrate a linear relationship to each other for Beta-Hydroxybutyric Acid. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Beta- Hydroxybutyric Acid. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling and may be used as quality control material for Beta-Hydroxybutyric Acid. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit® MicroCV™ Beta- Hydroxybutyric Acid Linearity Set should not be used for calibration or standardization of the Beta- Hydroxybutyric Acid assay. The Audit® MicroCV™ Beta- Hydroxybutyric Acid Linearity Set is "For In Vitro Diagnostic Use Only".

The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is an assayed quality control material consisting of five levels of human based serum, with each level containing Beta-Hydroxybutyric Acid. It is used to confirm the proper calibration, linear operating range, and reportable range of Beta-Hydroxybutyric Acid. Level A is near the lower limit level and Level E has concentrations near the upper limit of instruments. Levels B - D are related by linear dilution of Level A and Level E.

Audit® MicroLQ™ Spinal Fluid Control is a quality control material intended for monitoring the precision of laboratory testing procedures. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit® MicroLQ™ Spinal Fluid is for In Vitro Diagnostic use only.

The Audit® MicroLQ™ Spinal Fluid is a human based, liquid set of QC material. Each level of the set contains Chloride, Glucose, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Lactate, Lactate Dehydogenase (LD), Microalbumin, Microprotein, and Sodium analytes. It is used to confirm the proper calibration of Chloride, Glucose, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Lactate, Lactate Dehydogenase (LD), Microalbumin, Microprotein, and Sodium

The Audit™ MicroCV™ Urine/Fluids Chemistry Linearity Set is assayed quality control material consisting of two sets of five levels of aqueous buffer. Each level of Set 1 contains the following analytes: Phosphorous, Urea Nitrogen, Uric Acid. Each level of Set 2 contains the following analytes: Amylase, Calcium, Glucose, Chloride, Creatinine, Magnesium, Potassium, Sodium, Microprotein, Microalbumin, These five levels of each set demonstrate a linear relationship to each other for their respective analytes, reagents and instruments. The product is intended for use with quantitative assays on the indicated analyzer specified in the labeling. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit™ MicroCV™ Urine/Fluids Chemistry Linearity Set is "For In Vitro Diagnostic Use Only".

The Audit® MicroCV™ Urine/Fluids Chemistry Linearity is a aqueous buffer based, lyophilized, two five level sets of QC material, with each level of the first set containing Phosphorous, Urea Nitrogen, Uric Acid.and the second set containing Amylase, Calcium, Chloride, Creatinine, Glucose, Magnesium, Microalbumin, Microprotein, Potassium, Sodium. It is used to confirm the proper calibration, linear operating range, and reportable range of Phosphorous, Urea Nitrogen, Uric Acid, Amylase, Calcium, Chloride, Creatinine, Glucose, Magnesium, Microalbumin, Microprotein, Potassium, Sodium Level A is near the lower limit level and Level E has concentrations near the upper limit of instruments. Levels B - D are related by linear dilution of Level A and Level E.

Audit® MicroCV™ T-Uptake Calibration/Verification Set consists of five levels of human and bovine albumin based serum containing T-Uptake. The Audit® MicroCV™ T-Uptake Calibration/Verification Set is a quality control material intended for use in the quantitative verification of calibration and reportable range of the Roche T-uptake Assay when performed on the P-Modular Analyzer When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit® MicroCV™ T-Uptake Calibration/Verification is for In Vitro Diagnostic use only.

The Audit® MicroCV™ T-Uptake Calibration/Verification is a human and bovine albumin based, liquid set of QC material. Each level of the set contains T-Uptake analyte. It is used to confirm the proper calibration, linear operating range, and reportable range of T-Uptake. Level A is near the lower limit level and Level E has concentrations near the upper limit of P-Modular analyzer. Levels B, C, and D are prepared in a manner such that an equal distance exists between each consecutive level.

Audit® MicroLQ™ Serum Protein Control is an assayed, ready-to-use liquid, bi-level, human serum -based control for use with assays designed to quantitate: Immunoglobulin E (IgE), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), Prealbumin, Antithrombin III, Alpha-1-Antitrypsin (AAT), Albumin, Complement C4 (C4), Complement C3 (C3), alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin. It is intended to simulate human patient samples for the purpose of monitoring the precision of laboratory testing procedures for Immunoglobulin E (IgE), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), Prealbumin, Antithrombin III, Alpha-1-Antitrypsin (AAT), Albumin, Complement C4 (C4), Complement C3 (C3), alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin assays. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The product is intended for use with quantitative assays on the Beckman Immage 800. The Audit® MicroLQ™ Serum Protein Control is for In Vitro Diagnostic use only.

The Audit® MicroLQ™ Serum Protein Control is a human based, liquid set of QC material. Each level of the set contains Immunoglobulin E (IgE), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), Prealbumin, Antithrombin III, Alpha-1-Antitrypsin (AAT), Albumin, Complement C4 (C4), Complement C3 (C3), alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin analytes. It is used to confirm the proper calibration of Immunoglobulin E (IgE), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), Prealbumin, Antithrombin III. Alpha-1-Antitrypsin (AAT), Albumin, Complement C4 (C4), Complement C3 (C3), alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin.