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Address: 13000 South Memorial Pkwy., Huntsville, Alabama 35803, USA
Phone: +1-(256)-882-4800
FDA Registration: 1037998
Products: Glucose Monitoring Systems, Glucose Monitoring, Glucose Monitors, Over-The-Counter Blood Glucose Test System (FDA Code:
NBW), Therapeutic Automated Blood Cell and Plasma Separator (FDA Code:
LKN), Microwave Hyperthermia System (FDA Code:
MEQ), ...
Sanmina-SCI USA, Inc. offers microwave hyperthermia systems, and glucose monitoring systems.
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Address: 155 Jefferson Dr., Menlo Park, California 94025, USA
www.apieron.com |
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Phone: +1-(650)-838-8200
Products: Asthma Management Kit, Breath Nitric Oxide Test System (FDA Code:
MXA), ...
Apieron deals with asthma care devices. Our Insight™ eNO system is an asthma device that utilizes a patented biosensor technology to provide safe, accurate and non-invasive measurement of exhale
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Address: Sundbybergsvagen 9, Solna 17173, Sweden
www.aerocrine.com |
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Phone: +46-(8)-629-0786
Products: Healthcare Service, Monitoring Systems, Clinical Applications Training Kit, Breath Nitric Oxide Test System (FDA Code:
MXA), ...
Aerocrine Ab manufactures monitoring devices for research and clinical applications. Our products are used to help doctors to diagnose, monitor and optimize therapy for people with inflammatory airway
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FDA Code / Regulation: MXA / 862.3080 A breath nitric oxide test system is a device intended to measure fractional nitric oxide in human breath. Measurement of changes in fractional nitric oxide concentration in expired breath aids in evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to established clinical and laboratory assessments of asthma. A breath nitric oxide test system combines chemiluminescence detection of nitric oxide with a pneumotachograph, display, and dedicated software.
Classification. Class II (special controls). The special control is FDA's guidance entitled "Class II Special Controls Guidance Document: Breath Nitric Oxide Test System." See 862.1(d) for the availability of this guidance document.