21 CFR 864.2260
§ 864.2260 Chromosome culture kit.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 864.2260, § 864.2260 Chromosome culture kit, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89311
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Full text
(a) 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.
(b) Classification. 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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.