21 CFR 864.2800 — Sera, Animal And Human
Hematology (HE) · Part 864 Subpart C—Cell And Tissue Culture Products · § 864.2800
Identification
Animal and human sera are biological products, obtained from the blood of humans or other animals, that provide the necessary growth-promoting nutrients in a cell culture system.
Classification Rationale
Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KIS | Sera, Animal And Human | 1 | 45 |
