Profile: Nanosphere, Inc. is a nanotechnology-based healthcare company. We offer technologies that provide a solution to simplify diagnostic testing. In the molecular diagnostics market, we have developed tests for the following areas: genetics, pharmacogenetics, infectious diseases and oncology. Our products are the verigener system, which is a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid and protein targets & verigener nucleic acid tests.
FDA Registration Number: 3006028115
11 Products/Services (Click for related suppliers)
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| • Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System (FDA Code: ODW / 862.3360) A drug metabolizing enzyme genotyping system is a device intended for use in testing deoxyribonucleic acid (DNA) extracted from clinical samples to identify the presence or absence of human genotypic markers encoding a drug metabolizing enzyme. This device is used as an aid in determining treatment choice and individualizing treatment dose for therapeutics that are metabolized primarily by the specific enzyme about which the system provides genotypic information. |
| • Gene Mutation Detection, Cystic Fibrosis Transmembrane Conductance Regulator System (FDA Code: NUA / 866.5900) |
| • Genomic Dna Pcr 10-Methylenetetrahydrofolate Reductase Mutations Test 5 (FDA Code: OMM / 864.7280) Factor V Leiden deoxyribonucleic acid (DNA) mutation detection systems are devices that consist of different reagents and instruments which include polymerase chain reaction (PCR) primers, hybridization matrices, thermal cyclers, imagers, and software packages. The detection of the Factor V Leiden mutation aids in the diagnosis of patients with suspected thrombophilia. |
| • Genomic Dna Pcr Factor Ii G20210a Mutations Test (FDA Code: NPR / 864.7280) |
| • Genomic Dna Pcr Factor V Leiden Mutations Test (FDA Code: NPQ / 864.7280) |
| • High-Sensitivity Protein Diagnostics |
| • Instrumentation For Clinical Multiplex Test Systems (FDA Code: NSU / 862.2570) |
| • Micro Chemistry Analyzer (FDA Code: JJF / 862.2170) A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes. |
| • Molecular Diagnostics Workstations |
| • Respiratory Virus Panel Nucleic Acid Assay System (FDA Code: OCC / 866.3980) A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses: |
| • Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System (FDA Code: ODV / 864.7750) A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism). |