21 CFR 864.7500
§ 864.7500 Whole blood hemoglobin assays.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 864.7500, § 864.7500 Whole blood hemoglobin assays, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89382
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.