Inter- alpha trypsin inhibitor immunological test system.

(a) Identification. An inter- alpha trypsin inhibitor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the inter- alpha trypsin inhibitor (a protein) in serum and other body fluids. Measurement of inter- alpha trypsin inhibitor may aid in the diagnosis of acute bacterial infection and inflammation. (b) 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 § 866.9. [47 FR 50823, Nov. 9, 1982, as amended at 53 FR 11253, Apr. 6, 1988; 65 FR 2313, Jan. 14, 2000]