21 C.F.R. § 862.1330

Current through September 30, 2024
Section 862.1330 - Globulin test system
(a)Identification. A globulin test system is a device intended to measure globulins (proteins) in plasma and serum. Measurements of globulin are used in the diagnosis and treatment of patients with numerous illnesses including severe liver and renal disease, multiple myeloma, and other disorders of blood globulins.
(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 § 862.9 .

21 C.F.R. §862.1330

52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000