21 CFR 864.8185
§ 864.8185 Calibrator for red cell and white cell counting.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.8185, § 864.8185 Calibrator for red cell and white cell counting, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89399
- Permanent ID
ys:prov:89399@1- SHA-256
cfb784a3f1ffdeeab6bc4183798e48e19817a2938df136ad47e89a1154956746
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Full text
(a) Identification. A calibrator for red cell and white cell counting is a device that resembles red or white blood cells and that is used to set instruments intended to count red cells, white cells, or both. It is a suspension of particles or cells whose size, shape, concentration, and other characteristics have been precisely and accurately determined.
(b) Classification. Class II (special 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.