Profile: Varian Medical Systems, Inc. delivers specialized non-invasive, image-guided radiosurgery tools that serve as a complement to traditional surgery. We deal in X-ray tubes & flat panel detectors, which serve manufacturers of imaging equipment for medical diagnostics, as well as industrial inspection and security products. We render accelerating port and border safety with high-energy X-ray devices for cargo security & non-destructive testing applications. Our PaxScan® line of ultra-fast flat-panel digital X-ray image detectors are used to capture X-ray images and instantly display them on computer screens, eliminating the need for film and film processing.

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FDA Registration Number: 3007157255

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• Alcohol Potassium Dichromate Test (FDA Code: DOJ / 862.3040) An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.

• 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.

• 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.

• Cannabinoids Enzyme Immunoassay Test (FDA Code: LDJ / 862.3870) A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.

• Cardiac Catheterization Equipment Spare Parts

• Ceramic X-Ray Tubes

• Cocaine and Cocaine Metabolites Enzyme Immunoassay Test (FDA Code: DIO / 862.3250) A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

• Collimators

• Common Radiotherapy Simulator

• Computed Tomography

• Computed Tomography X-Ray System (FDA Code: JAK / 892.1750) A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Computerized Tomography CT Tubes

• Contract Manufacturers

• Conventional Radiotherapy Simulator

• CT (computed Tomography) Spare Parts

• CT Tube Spare Parts

• CT Tubes

• Diagnostic X-Ray Tube Housing Assembly (FDA Code: ITY / 892.1760) A diagnostic x-ray tube housing assembly is an x-ray generating tube encased in a radiation-shielded housing that is intended for diagnostic purposes. This generic type of device may include high voltage and filament transformers or other appropriate components.

• Digital Radiography

• Digital Radiotherapy Simulator

• Digital X-Ray Image Detectors

• Education & Training

• EPR (electronic Patient Record) Devices

• High Pressure Liquid Chromatography Instrumentation (FDA Code: LDM / 862.2260) A high pressure liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a solution by processing the mixture of compounds (solutes) through a column packed with materials of uniform size (stationary phase) under the influence of a high pressure liquid (mobile phase). Separation of the solutes occurs either by absorption, sieving, partition, or selective affinity.

• High Voltage Therapeutic X-Ray Collimator (FDA Code: IYK / 892.5900) An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

• IGRT (Image-guided Radiation Therapy) Device

• Image Intensification System

• Image-guided Radiation Therapy Device Spare Parts

• Image-guided Radiation Therapy Devices Maintenance Services

• Image-guided Radiation Therapy Kits

• IMRT (Intensity Modulated Radiation Therapy) Devices

• IMRT (Intensity Modulated Radiation Therapy) Installation Service

• Industrial X-Ray Tube

• Intensity Modulated Radiation Therapy Repair Services

• Ion-Exchange Chromatography (FDA Code: DJY / 862.2230) A chromatographic separation material for clinical use is a device accessory (e.g., ion exchange absorbents, ion exchagne resins, and ion papers) intended for use in ion exchange chromatography, a procedure in which a compound is separated from a solution.

• Linear Accelerator Repair Services

• Linear Accelerators

• Mammography Spares

• Medical Charged-Particle Radiotherapy Unit (FDA Code: LHN / 892.5050) A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

• Medical Linear Accelerator (FDA Code: IYE / 892.5050)

• Methamphetamine Gas Chromatography Test (FDA Code: LAF / 862.3610) A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.

• Morphine Fluorometry Test (FDA Code: DJJ / 862.3640) A morphine test system is a device intended to measure morphine, an addictive narcotic pain-relieving drug, and its analogs in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of morphine use or overdose and in monitoring levels of morphine and its analogs to ensure appropriate therapy.

• NAD/NADH Reagent for Alcohol Enzume Method (FDA Code: DML / 862.3040)

• Neurological Stereotaxic Instrument (FDA Code: HAW / 882.4560) A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

• Non-Sterile Specimen Container (FDA Code: NNI / 864.3250) A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.

• Non-Sterile Specimen Mailer And Storage Container (FDA Code: NNK / 864.3250)

• Opiates Enzyme Immunoassay Test (FDA Code: DJG / 862.3650) An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

• Opiates Thin Layer Chromatography Test (FDA Code: LAI / 862.3650)

• Phencyclidine Enzyme Immunoassay (FDA Code: LCM)