21 CFR 864.5950 — Device, Blood Volume Measuring

Hematology (HE) · Part 864 Subpart F—Automated and Semi-Automated Hematology Devices · § 864.5950

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.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
JWODevice, Blood Volume Measuring223rd Party
Innolitics

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