21 CFR § 866.5440 - Beta-2-glycoprotein III immunological test system.
(a) 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.
(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.
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