Automated Urinalysis System Manufacturers

Automated Urinalysis System offers increased accuracy, sensitivity and objective quantifiable determinations of urinary constituents for better diagnostic interpretation of the test results of urine. The automated urinalysis system enables a technician to take a sample of urine and place it on an auto analyzer that contains the system reagent materials for the referenced tests, start the self-operating analyzer and walk away to other duties until the results are reported by the analyzer.

FDA Code / Regulation: KQO / 862.2900    FDA Device Name: Automated Urinalysis System

Identification. An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.