866.5400—Alpha -globulin immuno-logical test system.

(a) 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.

(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.

Code of Federal Regulations

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]

CFR

866.5400—Alpha -globulin immuno-logical test system.

Code of Federal Regulations