21 C.F.R. § 864.7500

Current through September 30, 2024
Section 864.7500 - Whole blood hemoglobin assays
(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 (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9 .

21 C.F.R. §864.7500

45 FR 60622, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019
84 FR 71799, 12/30/2019