17-Hydroxycorticosteroids Porter Silber Hydrazone,17-Hydroxyprogesterone Radioimmunoassay Test Suppliers & Manufacturers

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17-Hydroxycorticosteroids Porter Silber Hydrazone (FDA Code: CDB / 862.1385)

Identification. A 17-hydroxycorticosteroids (17-ketogenic steroids) test system is a device intended to measure corticosteroids that possess a dihydroxyacetone

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.

Biochemical Diagnostics, Inc.

17-Hydroxyprogesterone Radioimmunoassay Test (FDA Code: JLX / 862.1395)

Identification. A 17-hydroxyprogesterone test system is a device intended to measure 17-hydroxyprogesterone (a steroid) in plasma and serum. Measurements of 17-hydroxyprogesterone are used in the diagnosis and treatment of various disorders of the adrenal glands or the ovaries.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.

Siemens Healthcare Diagnostics, PerkinElmer, Inc.(LAS), DRG International, Inc., more...

17-Ketogenic Steroids Zimmerman/Norymberski (FDA Code: CCZ / 862.1385)

Identification. A 17-hydroxycorticosteroids (17-ketogenic steroids) test system is a device intended to measure corticosteroids that possess a dihydroxyacetone

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.

Biochemical Diagnostics, Inc.

17-Ketosteroids Zimmerman (Spectrophotometric) (FDA Code: CCY / 862.1430)

Identification. A 17-ketosteroids test system is a device intended to measure 17-ketosteroids in urine. Measurements of 17-ketosteroids are used in the diagnosis and treatment of disorders of the adrenal cortex and gonads and of other endocrine disorders, including hypertension, diabetes, and hypothyroidism.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.

Biochemical Diagnostics, Inc., Modern Healthcare Corp.

3-Tiler Test Tube Stand
Bio-Rad Laboratories, Inc., Kimble Chase Life Science and Research Products LLC, Midwest Scientific, more...

4-dinitrophenylhydrazine 2 Ascorbic Acid (FDA Code: JMA / 862.1095)

Identification. 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.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.

Teco Diagnostics, Diagnostic Automation, Inc., Iris Diagnostics, more...

5'-Nucleotidase 5-AMP-Phosphate Release (Colorimetric Test) (FDA Code: CED / 862.1520)

Identification. A 5'-nucleotidase test system is a device intended to measure the activity of the enzyme 5'-nucleotidase in serum and plasma. Measurements of 5'-nucleotidase are used in the diagnosis and treatment of liver diseases and in the differentiations between liver and bone diseases in the presence of elevated serum alkaline phosphatase activity.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.

Diazyme Laboratories, Fisher Scientific International, Inc., Catachem Inc., more...

Accelerometer
Individual Monitoring Systems, Inc., Kistler Instrument Corp., Biometrics Ltd., more...

Acetone
Siemens Healthcare Diagnostics, Fisher Scientific International, Inc., Biomerieux Industry, more...

Acid Phosphatase, Naphthyl Phosphate Test (FDA Code: CKB / 862.1020)

Identification. 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.

Classification. Class II.

Teco Diagnostics, Abbott Diagnostics, Siemens Healthcare Diagnostics, more...

Acid Phosphatase, Nitrophenylphosphate Test (FDA Code: CJN / 862.1020)

Identification. 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.

Classification. Class II.

Wiener Laboratorios SAIC

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

Identification. 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.

Classification. Class II.

Teco Diagnostics, International Bio-Analytical Industries, Inc., Siemens Healthcare Diagnostics, more...

Acid, Hydroxyazobenzene-Benzoic, Albumin (FDA Code: CJZ / 862.1035)

Identification. 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.

Classification. Class II.

Siemens Healthcare Diagnostics, Hemagen Diagnostics, Inc., Fisher Scientific International, Inc., more...

ACTH Radioimmunoassay Test (FDA Code: CKG / 862.1025)

Identification. An adrenocorticotropic hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma and serum. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.

Classification. Class II.

Biomerica, Nichols Institute Diagnostics, Scantibodies Laboratory, Inc., more...

Albumin Cobalt Binding Test (FDA Code: NJV / 862.1215)

Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Classification. Class II.

Inverness Medical Innovations, Inc.

Albumin Radial Immunodiffusion Test (FDA Code: CJQ / 862.1035)

Identification. 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.

Classification. Class II.

The Binding Site, Kent Laboratories, Inc.

Albumin Tetrabromo-M-Cresolsulfonphthalein Test (FDA Code: CJG / 862.1035)

Identification. 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.

Classification. Class II.

Siemens Healthcare Diagnostics, Biomerieux Industry

Aldolase Hydrazone Colorimetry Test (FDA Code: CJT / 862.1040)

Identification. An aldolase test system is a device intended to measure the activity of the enzyme aldolase in serum or plasma. Aldolase measurements are used in the diagnosis and treatment of the early stages of acute hepatitis and for certain muscle diseases such as progressive Duchenne-type muscular dystrophy.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.

Organon Teknika B.V.

Aldosterone Chromatographic Separation/Radioimmunoassay Test (FDA Code: CJB / 862.1045)

Identification. An aldosterone test system is a device intended to measure the hormone aldosterone in serum and urine. Aldosterone measurements are used in the diagnosis and treatment of primary aldosteronism (a disorder caused by the excessive secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states, and other conditions of electrolyte imbalance.

Classification. Class II.

DiaSorin S.p.A., Nantong Strip Medical Supply Co., Ltd

Aldosterone Radioimmunoassay Test (FDA Code: CJM / 862.1045)

Identification. An aldosterone test system is a device intended to measure the hormone aldosterone in serum and urine. Aldosterone measurements are used in the diagnosis and treatment of primary aldosteronism (a disorder caused by the excessive secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states, and other conditions of electrolyte imbalance.

Classification. Class II.

Diagnostic Automation, Inc., Siemens Healthcare Diagnostics, DRG International, Inc., more...

Alkaline Phosphatase Isoenzymes Electrophoretic Separation Test (FDA Code: CIN / 862.1050)

Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Classification. Class II.

Quidel Corporation, Siemens Healthcare Diagnostics, Perkinelmer, Inc., more...

Alkaline Phosphatase, Phenolphthalein Phosphate Test (FDA Code: CJK / 862.1050)

Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Classification. Class II.

Siemens Healthcare Diagnostics, Olympus America, Inc., Beckman Coulter, Inc., more...

Alkaline Phosphatase, Phenylphosphate Test (FDA Code: CKF / 862.1050)

Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Classification. Class II.

Quidel Corporation, Abaxis, Inc, Biomerieux Industry, more...

Alkaline Picrate Creatinine Colorimetric Method (FDA Code: CGX / 862.1225)

Identification. 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.

Classification. Class II.

Teco Diagnostics, Abaxis, Inc, International Bio-Analytical Industries, Inc., more...

Alpha-Fetoprotein Rapid Test Strip
ACON Laboratories, Inc., Inova Diagnostics, Inc., Schueler & Company Inc, more...

Alpha-Ketobutyric Acid and NADH (FDA Code: JMK / 862.1380)

Identification. 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.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 862.9.

Teco Diagnostics, Siemens Healthcare Diagnostics, Polymer Technology Systems Inc., more...

Alt/Sgpt Diazo (FDA Code: CJJ / 862.1030)

Identification. An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.

GlobalEmed, Egyptian Co. For Biotechnology

ALT/SGPT Vanillin Pyruvate Test (FDA Code: CKC / 862.1030)

Identification. An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.

Egyptian Co. For Biotechnology, Wiener Laboratorios SAIC

Amino-Nitrogen (FDA Code: JMX / 862.1515)

Identification. A nitrogen (amino-nitrogen) test system is a device intended to measure amino acid nitrogen levels in serum, plasma, and urine. Nitrogen (amino-nitrogen) measurements are used in the diagnosis and treatment of certain forms of severe liver disease and renal disorders.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 862.9.

Beckman Coulter, Inc.

Ammonia Enzymatic Method Test (FDA Code: JIF / 862.1065)

Identification. 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.

Classification. Class I.

Teco Diagnostics, Abbott Diagnostics, Siemens Healthcare Diagnostics, more...

Ammonia Photometric Method (FDA Code: JID / 862.1065)

Identification. 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.

Classification. Class I.

Ortho-clinical Diagnostics, Inc.

Amphetamine Test Strip
ACON Laboratories, Inc., Inova Diagnostics, Inc., Schueler & Company Inc, more...

Amylase Catalytic Method Test (FDA Code: JFJ / 862.1070)

Identification. 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).

Classification. Class II.

Teco Diagnostics, Abaxis, Inc, International Bio-Analytical Industries, Inc., more...

Amylase Nephelometric (FDA Code: KHM / 862.1070)

Identification. 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).

Classification. Class II.

Siemens Healthcare Diagnostics, Olympus America, Inc., Beckman Coulter, Inc., more...

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

Identification. 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).

Classification. Class II.

Teco Diagnostics

Amylase Saccharogenic Test (FDA Code: CIJ / 862.1070)

Identification. 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).

Classification. Class II.

Abaxis, Inc, Pointe Scientific, Inc., Genchem, Inc., more...

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

Identification. 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).

Classification. Class II.

Teco Diagnostics, International Bio-Analytical Industries, Inc., Remel, more...

Amyloclastic, Amylase (FDA Code: CJA / 862.1070)

Identification. 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).

Classification. Class II.

Siemens Healthcare Diagnostics, Hemagen Diagnostics, Inc., Stanbio Laboratory, more...

Anaerotestr Test Strips
ACON Laboratories, Inc., Inova Diagnostics, Inc., Schueler & Company Inc, more...

Analytical Balances (FDA Code: JQO / 862.2050)

Identification. General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.

Classification. Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 862.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

A&D Medical, Utech Products, Inc., Clean Air Engineering, more...

Androstenedione Radioimmunoassay Test (FDA Code: CIZ / 862.1075)

Identification. An androstenedione test system is a device intended to measure androstenedione (a substance secreted by the testes, ovary, and adrenal glands) in serum. Adrostenedione measurements are used in the diagnosis and treatment of females with excessive levels of androgen (male sex hormone) production.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.

Diagnostic Automation, Inc., Siemens Healthcare Diagnostics, DRG International, Inc., more...

Angiotensin Converting Enzyme Radioassay (FDA Code: KQN / 862.1090)

Identification. An angiotensin converting enzyme (A.C.E.) test system is a device intended to measure the activity of angiotensin converting enzyme in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of diseases such as sarcoidosis, a disease characterized by the formation of nodules in the lungs, bones, and skin, and Gaucher's disease, a hereditary disorder affecting the spleen.

Classification. Class II.

Remel, Alpco Diagnostics, Mardx Diagnostics, Inc., more...

Angiotensin I and Renin Radioimmunoassay Test (FDA Code: CIB / 862.1085)

Identification. An angiotensin I and renin test system is a device intended to measure the level of angiotensin I generated by renin in plasma. Angiotensin I measurements are used in the diagnosis and treatment of certain types of hypertension.

Classification. Class II.

Nichols Institute Diagnostics, Alpco Diagnostics, Diagnostic Systems Laboratories, Inc., more...

Apolipoproteins (FDA Code: MSJ / 862.1475)

Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.

Diazyme Laboratories, Siemens Healthcare Diagnostics, DRG International, Inc., more...

Arterial Blood Gas Samplers
Hamilton Company, Nasorcap Medical, Inc., Spectrex Corp., more...

Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX / 862.1660)

Identification. 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.

Classification. Class I (general controls). Except when used in donor screening tests, unassayed material is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.

Teco Diagnostics, Qualigen Inc., Hycor Biomedical Inc., more...

AST/SGOT Catalytic Method Test
Wiener Laboratorios SAIC

Ast/Sgot Nadh Oxidation/Nad Reduction (FDA Code: CIT / 862.1100)

Identification. 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.

Classification. Class II.

Teco Diagnostics, Abaxis, Inc, International Bio-Analytical Industries, Inc., more...

AST/SGOT Vanillin Pyruvate Test (FDA Code: CIF / 862.1100)

Identification. 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.

Classification. Class II.

Wiener Laboratorios SAIC

Automated Radioimmunoassay Chemistry Analyzer
Siemens Healthcare Diagnostics, Capintec, Inc., Beckman Coulter, Inc., more...

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