§ 866.4100. Complement reagent.
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/us/cfr/t21/s§ 866.4100A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]