21 CFR 862.1330
§ 862.1330 Globulin test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1330, § 862.1330 Globulin test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89106
- Permanent ID
ys:prov:89106@1- SHA-256
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.