21 CFR 866.5420
§ 866.5420
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 866.5420, § 866.5420, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89637
- Permanent ID
ys:prov:89637@1- SHA-256
a70aa07dd4805b72b450a4376eedca4b6412f16e270a96234bd587bfd3d2961c
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.