21 CFR 866.5380

§ 866.5380 Free secretory component immunological test system.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 866.5380, § 866.5380 Free secretory component immunological test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89635
Permanent ID: ys:prov:89635@1
SHA-256: fd5731313677d5045eb65e159402c1ef03bf6a28a17b8a27bb83327e1dac72ee

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Full text

(a) Identification. A free secretory component immunological test system is a device that consists of the reagents used to measure by immunochemical techniques free secretory component (normally a portion of the secretory IgA antibody molecule) in body fluids. Measurement of free secretory component (protein molecules) aids in the diagnosis or repetitive lung infections and other hypogammaglobulinemic conditions (low antibody levels). (b) Classification. Class II (special 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.