![]() |
Code of Federal Regulations (Last Updated: July 5, 2024) |
![]() |
Title 21 - Food and Drugs |
![]() |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
![]() |
SubChapter H - Medical Devices |
![]() |
Part 864 - Hematology and Pathology Devices |
![]() |
Subpart H - Hematology Kits and Packages |
§ 864.7440 - Electrophoretic hemoglobin analysis system.
Latest version.
-
§ 864.7440 Electrophoretic hemoglobin analysis system.
(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]