21 C.F.R. § 866.5250

Complement C 1 inhibitor (inactivator) immunological test system.

Last amended: 2016Year: 2026Length: 103 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 866.5250 (2026)

(a) Identification. A complement C 1 inhibitor (inactivator) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C 1 inhibitor (a plasma protein) in serum. Complement C 1 inhibitor occurs normally in plasma and blocks the action of the C 1 component of complement (a group of serum proteins which destroy infectious agents). Measurement of complement C 1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer). (b) Classification. Class II (performance standards).
21 C.F.R. § 866.5250: Complement C 1 inhibitor (inactivator) immunological test system. | Justis AI