21 C.F.R. § 864.8175 Calibrator for platelet counting.
Title 21 - Food and Drugs
(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 (performance standards). [45 FR 60633, Sept. 12, 1980]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart I—Hematology Reagents
§ 864.8175 Calibrator for platelet counting.
