21 C.F.R. § 866.4100 Complement reagent.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart E—Immunology Laboratory Equipment and Reagents
§ 866.4100 Complement reagent.
