21 C.F.R. § 864.7440 Electrophoretic hemoglobin analysis system.
Title 21 - Food and Drugs
(a) Identification. An electrophoretic hemoglobin analysis system is a device that electrophoretically separates and identifies normal and abnormal hemoglobin types as an aid in the diagnosis of anemia or erythrocytosis (increased total red cell mass) due to a hemoglobin abnormality. (b) Classification. Class II (performance standards). [45 FR 60620, Sept. 12, 1980]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart H—Hematology Kits and Packages
§ 864.7440 Electrophoretic hemoglobin analysis system.
