§866.4100. Complement reagent.
21 C.F.R. § 866.4100
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.
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.
Notes, amendments, and revision history
Amendments
[47 FR 50823, Nov. 9, 2001, as amended at 66 FR 38792, July 25, 2001]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 47 FR 50823, Nov. 9, 1982, unless otherwise noted.
Amendments
[47 FR 50823, Nov. 9, 2001, as amended at 66 FR 38792, July 25, 2001]