§866.5440. Beta -2-glycoprotein III immunological test system.

Identification. A beta-2-glycoprotein III immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the beta-2-glycoprotein III (a serum protein) in serum and other body fluids. Measurement of beta-2-glycoprotein III aids in the diagnosis of an inherited deficiency of this serum protein 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.