Blood cell diluent.
21 C.F.R. § 864.8200
in effectEffective: 2024-07-01(a) Identification. A blood cell diluent is a device used to dilute blood for further testing, such as blood cell counting.
(b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026