866.5420—Alpha -1-glycoproteins immunological test system.

(a) Identification. An alpha- 1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniques alpha- 1-glycoproteins (a group of plasma proteins found in the alpha- 1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specific alpha- 1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.

(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

866.5420—Alpha -1-glycoproteins immunological test system.

Code of Federal Regulations