21 C.F.R. § 864.7500 Whole blood hemoglobin assays.
Title 21 - Food and Drugs
(a) Identification. A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems. (b) Classification. Class II (performance standards). [45 FR 60622, Sept. 12, 1980]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart H—Hematology Kits and Packages
§ 864.7500 Whole blood hemoglobin assays.
