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47 FR 50823, Nov. 9, 1982, unless otherwise noted.
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Nomenclature changes to part 866 appear at 73 FR 35341, June 23, 2008.
(a) Identification. A complement reagent is a device that consists of complement, a naturally occurring serum protein from any warm-blooded animal such as guinea pigs, that may be included as a component part of serological test kits used in the diagnosis of disease.
(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.
[47 FR 50823, Nov. 9, 2001, as amended at 66 FR 38792, July 25, 2001]