21 CFR 866.5330

§ 866.5330 Factor XIII, A, S, immunological test system.

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

Cite this

Citation: 21 CFR 866.5330, § 866.5330 Factor XIII, A, S, immunological test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89630
Permanent ID: ys:prov:89630@1
SHA-256: 9555b34bd812b4157d217d0defd5323391b6fbf0868a50dde081cdc20e43ca99

The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.

Full text

(a) Identification. A factor XIII, A, S, immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the factor XIII (a bloodclotting factor), in platelets (A) or serum (S). Measurements of factor XIII, A, S, aid in the diagnosis and treatment of certain bleeding disorders resulting from a deficiency of this factor. (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. This exemption does not apply to factor deficiency tests classified under § 864.7290 of this chapter.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.