21 CFR 866.3210

§ 866.3210 Endotoxin assay.

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

Cite this

Citation: 21 CFR 866.3210, § 866.3210 Endotoxin assay, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89504
Permanent ID: ys:prov:89504@1
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Full text

(a) Identification. An endotoxin assay is a device that uses serological techniques in whole blood. The device is intended for use in conjunction with other laboratory findings and clinical assessment of the patient to aid in the risk assessment of critically ill patients for progression to severe sepsis. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance entitled “Class II Special Controls Guidance Document: Endotoxin Assay.” See § 866.1(e) for the availability of this guidance document.

Legislative history

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