CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 864—HEMATOLOGY AND PATHOLOGY DEVICES > SUBPART I—Hematology Reagents (§864.8100 to §864.8950) > 864.8175—Calibrator for platelet counting.

864.8175—Calibrator for platelet counting.

(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).

Code of Federal Regulations

[45 FR 60633, Sept. 12, 1980]