21 CFR 864.2280 — Cells, Animal And Human, Cultured
Hematology (HE) · Part 864 Subpart C—Cell And Tissue Culture Products · § 864.2280
Identification
Cultured animal and human cells are in vitro cultivated cell lines from the tissue of humans or other animals which are used in various diagnostic procedures, particularly diagnostic virology and cytogenetic studies.
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 § 864.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KIR | Cells, Animal And Human, Cultured | 1 | 170 |
