21 C.F.R. · Food and Drugs
21 C.F.R. § 862.1330

Globulin test system.

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Regulatory Text

21 C.F.R. § 862.1330 — Globulin test system.

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

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21 C.F.R. § 862.1330
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The regulatory text of 21 C.F.R. § 862.1330 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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