Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 8 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER H - MEDICAL DEVICES
/ PART 864 - HEMATOLOGY AND PATHOLOGY DEVICES
/ Subpart F - Automated and Semi-Automated Hematology Devices / § 864.5620 Automated hemoglobin system.
§ 864.5620 Automated hemoglobin system.
(a) Identification. An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.
(b) Classification. Class II (performance standards).