21 CFR 864.8175
§ 864.8175 Calibrator for platelet counting.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.8175, § 864.8175 Calibrator for platelet counting, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89398
- Permanent ID
ys:prov:89398@1- SHA-256
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Full text
(a) Identification. A calibrator for platelet counting is a device that resembles platelets in plasma or whole blood and that is used to set a platelet counting instrument. 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.