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 H—Hematology Kits and Packages (§864.7040 to §864.7925) > 864.7100—Red blood cell enzyme assay.

864.7100—Red blood cell enzyme assay.

(a) Identification. Red blood cell enzyme assay is a device used to measure the activity in red blood cells of clinically important enzymatic reactions and their products, such as pyruvate kinase or 2,3-diphosphoglycerate. A red blood cell enzyme assay is used to determine the enzyme defects responsible for a patient's hereditary hemolytic anemia.
(b) Classification. Class II (performance standards).

Code of Federal Regulations

[45 FR 60610, Sept. 12, 1980]