Part 864 Subpart C—Cell And Tissue Culture Products
FDA submissions for Part 864 Subpart C—Cell And Tissue Culture Products in the Hematology (HE) review panel, including product codes and regulations.
Section range: §§ 864.2220–864.2875
CFR Part: 864
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| KIT | Media And Components, Synthetic Cell And Tissue Culture | 864.2220 | 1 | 367 |
| KIY | Chamber, Slide Culture | 864.2240 | 1 | 1 |
| KIZ | Dish, Tissue Culture | 864.2240 | 1 | 8 |
| KJA | Flask, Tissue Culture | 864.2240 | 1 | 13 |
| KJB | Apparatus, Roller | 864.2240 | 1 | 3 |
| KJC | Bottle, Roller, Tissue Culture | 864.2240 | 1 | 3 |
| KJD | Spinner, Flask | 864.2240 | 1 | 0 |
| KJE | Spinner System, Cell Culture | 864.2240 | 1 | 0 |
| KJF | System, Suspension, Cell Culture | 864.2240 | 1 | 4 |
| KJH | Apparatus, Perfusion | 864.2240 | 1 | 3 |
| NVG | Tissue Culture, Accessories, Dental | 864.2240 | 1 | 0 |
| KIQ | Kit, Culture, Chromosome | 864.2260 | 1 | 1 |
| KIR | Cells, Animal And Human, Cultured | 864.2280 | 1 | 170 |
| KIW | Kit, Mycoplasma Detection | 864.2360 | 1 | 2 |
| KIX | Media, Mycoplasma Detection | 864.2360 | 1 | 0 |
| KPB | Media And Components, Mycoplasma Detection | 864.2360 | 1 | 4 |
| KIS | Sera, Animal And Human | 864.2800 | 1 | 45 |
| KIP | Formulations, Balanced Salt Solutions | 864.2875 | 1 | 17 |
