Profile: Nanogen Inc focuses on diagnostics provide researchers, healthcare professionals and patients. We offer instrumentation, reagents and test kits. We develop biomedical and healthcare market products.
The company was founded in 1993. NASDAQ:NGEN (SEC Filings)
13 Products/Services (Click for related suppliers)
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| • Analyte Specific Reagents, Asr Reagents (FDA Code: MVU / 864.4020) Analyte specific reagents (ASR's) are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. ASR's that otherwise fall within this definition are not within the scope of subpart E of this part when they are sold to: |
| • 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. |
| • CPK Isoenzymes Chromatographic Separation Test (FDA Code: JHT / 862.1215) 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. |
| • Enzyme Controls (FDA Code: JJT / 862.1660) |
| • Fitc Myoglobin Antiserum Antigen Control (FDA Code: DEA / 866.5680) A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease. |
| • General Purpose Reagent (FDA Code: LDT) |
| • Genetic Testing Equipment |
| • Labeled Medical Laboratory Equipment (FDA Code: LXG / 862.2050) 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. |
| • Molecular Analyte Specific Reagents (ASR) |
| • Multi Analyte Control (FDA Code: JJY / 862.1660) |
| • Myoglobin (FDA Code: DDR / 866.5680) |
| • Natriuretic Peptide Test (FDA Code: NBC / 862.1117) The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure. |
| • Troponin Subunit Enzymatic Method (FDA Code: MMI / 862.1215) |