21 CFR 864.2260 — Kit, Culture, Chromosome
Hematology (HE) · Part 864 Subpart C—Cell And Tissue Culture Products · § 864.2260
Identification
A chromosome culture kit is a device containing the necessary ingredients (e.g., Minimum Essential Media (MEM) of McCoy's 5A culture media, phytohemagglutinin, fetal calf serum, antibiotics, and heparin) used to culture tissues for diagnosis of congenital chromosome abnormalities.
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 § 864.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KIQ | Kit, Culture, Chromosome | 1 | 1 |
