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Electronic Code of Federal Regulations

e-CFR data is current as of June 2, 2020

Title 21Chapter ISubchapter HPart 864Subpart F → §864.5950


Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart F—Automated and Semi-Automated Hematology Devices


§864.5950   Blood volume measuring device.

(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).

[45 FR 60603, Sept. 12, 1980]

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