(a) Identification. A beta -2-glycoprotein I immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the beta -2-glycoprotein I (a serum protein) in serum and other body fluids. Measurement of beta -2-glycoprotein I aids in the diagnosis of an inherited deficiency of this serum protein.
(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 65 FR 2312, Jan. 14, 2000]