21 CFR 866.5170

§ 866.5170 Breast milk immunological test system.

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

Cite this

Citation: 21 CFR 866.5170, § 866.5170 Breast milk immunological test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89619
Permanent ID: ys:prov:89619@1
SHA-256: 6a6bc847be08b6228d6f4a7b4417671e17bd7fe1ec0b2c58e3ac28f7c963a382

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Full text

(a) Identification. A breast milk immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the breast milk proteins. (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 the limitations in § 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.