21 CFR 866.4100 — Protein, Complement, Antigen, Antiserum, Control
Immunology (IM) · Part 866 Subpart E—Immunology Laboratory Equipment and Reagents · § 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 Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DHL | Protein, Complement, Antigen, Antiserum, Control | 1 | 4 | |
| KTQ | Reagent, Complement | 1 | 6 |
