21 CFR 866.5890
§ 866.5890 Inter-
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 866.5890, § 866.5890 Inter-, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89678
- Permanent ID
ys:prov:89678@1- SHA-256
8de5e32648b504a346ccd252be215659779f4114d5751d6a8c298c85bde0da97
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Full text
(a) Identification. An inter-alpha trypsin inhibitor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the inter-alpha trypsin inhibitor (a protein) in serum and other body fluids. Measurement of inter-alpha trypsin inhibitor may aid in the diagnosis of acute bacterial infection and inflammation.
(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.