§866.5400. Alpha -globulin immunological test system.

Identification. An alpha-globulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-globulin (a serum protein) in serum and other body fluids. Measurement of alpha-globulin may aid in the diagnosis of inflammatory lesions, infections, severe burns, and a variety of other conditions.

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.