Profile: Nova Biomedical specializes in biosensor technology. We produce whole blood analyzers to support the care of critically ill patients. Our stat profile pHOx series analyzers offer essential blood gas and critical care test menus in the smallest analyzers currently available in the industry. Our syringe clot catchers are designed specifically to prevent clots present in whole blood samples from entering the flow path of Nova Stat Profile® critical care Xpress blood gas/critical care analyzers. We offer products such as Nova hospital glucose monitoring system, POCT bedside glucose meter, and Nova StatStripT blood glucose monitoring system. The Nova StatStripT blood glucose monitoring system is used for neonatal testing of whole blood glucose in neonates. The StatStrip's 6-second analysis time, color touch screen operation, and simple operating steps make bedside glucose testing fast and easy for point of care staff. Unlike competitive glucose analyzers, StatStrip requires no calibration codes thereby eliminating an operator step and preventing a potential input error.

The company was founded in 1976, has revenues of USD 100-500 Million, has ~620 employees and is ISO 9001, CE certified.

FDA Registration Number: 1219029

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• Prothrombin Time Test (FDA Code: GJS / 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).

• Quality Assessment Programs

• Secondary Calibrator (FDA Code: JIT / 862.1150) A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also 862.2 in this part.)

• Sodium Ion Specific Electrode (FDA Code: JGS / 862.1665) A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

• Total Protein Biuret Method (FDA Code: CEK / 862.1635) A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.

• Urea Nitrogen Ion Specific Electrode (FDA Code: CDS / 862.1770) A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

• Urinary Occult Blood Enzymatic Method (FDA Code: JIP / 864.6550) An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)

• Whole Blood Oximeter (FDA Code: GLY / 864.7500) A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.