Code of Federal Regulations · Section

§ 864.5950 — Blood Volume Measuring Device

21 C.F.R. § 864.5950

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(a) Identification. A blood volume measuring device is a manual, semiautomated, or automated system that is used to calculate the red cell mass, plasma volume, and total blood volume.

(b) Classification. Class II (performance standards).

21 C.F.R. § 864.5850

Authorizing Statute