21 CFR 864.2240 — Chamber, Slide Culture
Hematology (HE) · Part 864 Subpart C—Cell And Tissue Culture Products · § 864.2240
Identification
Cell and tissue culture supplies and equipment are devices that are used to examine, propagate, nourish, or grow cells and tissue cultures. These include such articles as slide culture chambers, perfusion and roller apparatus, cell culture suspension systems, and tissue culture flasks, disks, tubes, and roller bottles.
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. If the devices are not labeled or otherwise represented as sterile, they are exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KIY | Chamber, Slide Culture | 1 | 1 | |
| KIZ | Dish, Tissue Culture | 1 | 8 | |
| KJA | Flask, Tissue Culture | 1 | 13 | |
| KJB | Apparatus, Roller | 1 | 3 | |
| KJC | Bottle, Roller, Tissue Culture | 1 | 3 | |
| KJD | Spinner, Flask | 1 | 0 | |
| KJE | Spinner System, Cell Culture | 1 | 0 | |
| KJF | System, Suspension, Cell Culture | 1 | 4 | |
| KJH | Apparatus, Perfusion | 1 | 3 | |
| NVG | Tissue Culture, Accessories, Dental | 1 | 0 |
