21 CFR 864.9320
§ 864.9320 Copper sulfate solution for specific gravity determinations.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.9320, § 864.9320 Copper sulfate solution for specific gravity determinations, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89422
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Full text
(a) Identification. A copper sulfate solution for specific gravity determinations is a device used to determine whether the hemoglobin content of a potential donor's blood meets the required level (12.5 grams per 100 milliliters of blood for women and 13.5 grams per 100 milliliters of blood for men).
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 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.