Profile: Teco Diagnostics is an ISO 13485 certified company. We offer a complete line of clinical chemistry reagents and urine reagent strips. Our one step pregnancy card test helps in obtaining a visual qualitative result for the detection of pregnancy. Our uritek-720 urine reagent strip reader incorporates flat bed, continuous feed method for fast reading & meeting the demands of high volume laboratories. Our tests refer to a variety of card and dipstick tests used to quickly and qualitatively determine the presence of a given substance in a sample. These tests are easily interpreted as positive or negative by the presence or absence of a color band in the test zone. Each test contains a built-in control line for added quality assurance. Rapid tests are useful for the testing of fertility, tumor markers, cardiac markers, infectious diseases, drug of abuse and drug adulteration.

FDA Registration Number: 1832216

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• 4-dinitrophenylhydrazine 2 Ascorbic Acid (FDA Code: JMA / 862.1095) An ascorbic acid test system is a device intended to measure the level of ascorbic acid (vitamin C) in plasma, serum, and urine. Ascorbic acid measurements are used in the diagnosis and treatment of ascorbic acid dietary deficiencies.

• Acid Phosphatase, Naphthyl Phosphate Test (FDA Code: CKB / 862.1020) An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum.

• Acid Phosphatase, Thymolphthalein Monophosphate Test (FDA Code: CKE / 862.1020)

• Activated Partial Thromboplastin (FDA Code: GFO / 864.7925) A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.

• Albumin

• Albumin Reagent Set

• Alkaline Phosphatase (ALP) (FDA Code: JCJ / 864.7660) A leukocyte alkaline phosphatase test is a device used to identify the enzyme leukocyte alkaline phosphatase in neutrophilic granulocytes (granular leukocytes stainable by neutral dyes). The cytochemical identification of alkaline phosphatase depends on the formation of blue granules in cells containing alkaline phosphatase. The results of this test are used to differentiate chronic granulocytic leukemia (a malignant disease characterized by excessive overgrowth of granulocytes in the bone marrow) and reactions that resemble true leukemia, such as those occuring in severe infections and polycythemia (increased total red cell mass).

• Alkaline Picrate Creatinine Colorimetric Method (FDA Code: CGX / 862.1225) A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

• Alpha Fetoprotein Microtiter Tests

• Alpha-Ketobutyric Acid and NADH (FDA Code: JMK / 862.1380) A hydroxybutyric dehydrogenase test system is a device intended to measure the activity of the enzyme alpha-hydroxybutric dehydrogenase (HBD) in plasma or serum. HBD measurements are used in the diagnosis and treatment of myocardial infarction, renal damage (such as rejection of transplants), certain hematological diseases (such as acute leukemias and megaloblastic anemias) and, to a lesser degree, liver disease.

• ALT (SGPT)

• Ammonia Enzymatic Method Test (FDA Code: JIF / 862.1065) An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.

• Ammonia Kit

• Ammonia Reagent Set

• Amphetamine Card Test

• Amphetamine Enzyme Immunoassay Test (FDA Code: DKZ / 862.3100) An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

• Amylase

• Amylase Catalytic Method Test (FDA Code: JFJ / 862.1070) An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

• Amylase Inhibitors

• Amylase Nitrosalicylate Reduction Test (FDA Code: CJD / 862.1070)

• Amylase Starch

• Amylase Starch-Dye Bound Polymer Test (FDA Code: CIW / 862.1070)

• Anesthesia Conduction Kit (FDA Code: CAZ / 868.5140) An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.

• Anesthetic Conduction Needle with/without Introducer (FDA Code: BSP / 868.5150) An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

• Antithrombin III Quantitation Test (FDA Code: JBQ / 864.7060) An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).

• Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX / 862.1660) A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

• Ast/Sgot Nadh Oxidation/Nad Reduction (FDA Code: CIT / 862.1100) An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

• Auto LDL-Cholesterol, automated analyzer test kits

• Automated Urinalysis System (FDA Code: KQO / 862.2900) An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.

• Barbiturate Enzyme Immunoassay Test (FDA Code: DIS / 862.3150) A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.

• Benzodiazepine Enzyme Immunoassay Test (FDA Code: JXM / 862.3170) A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.

• Beta-2-Microglobulin Immunological Test System (FDA Code: JZG / 866.5630) Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesbeta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

• Bile Acids Cholyglycine Radioimmunoassay (FDA Code: KWW / 862.1177) A cholylglycine test system is a device intended to measure the bile acid cholylglycine in serum. Measurements obtained by this device are used in the diagnosis and treatment of liver disorders, such as cirrhosis or obstructive liver disease.

• Bilirubin and Conjugates Colorimetric Azo-Dyes Test (FDA Code: JJB / 862.1115) A urinary bilirubin and its conjugates (nonquantitative) test system is a device intended to measure the levels of bilirubin conjugates in urine. Measurements of urinary bilirubin and its conjugates (nonquantitative) are used in the diagnosis and treatment of certain liver diseases.

• Bilirubin Diazo Colorimetry Test (FDA Code: CIG / 862.1110) A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

• Bilirubin Direct Reagent

• Bilirubin Total Reagent

• Blood Albumin Detector

• Blood Collection Systems (FDA Code: JKA / 862.1675) A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

• Blood Glucose Kits

• Blood Glucose Monitoring Systems

• Blood Glucose Monitoring Systems

• Blood Glucose Monitors

• Blood Glucose Test Strips

• Blood glucose testing

• Bromcresol Green Dye-Binding, Albumin (FDA Code: CIX / 862.1035) An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

• C-Reactive Protein (CRP), FITC Conjugate (FDA Code: DCK / 866.5270) A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

• C-Reactive Protein Test System (FDA Code: DCN / 866.5270)

• Calcium Cresolphthalein Complexone Test (FDA Code: CIC / 862.1145) A calcium test system is a device intended to measure the total calcium level in 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).

• Calcium Ion Specific Electrode (FDA Code: JFP / 862.1145)