21 CFR 864.6600
§ 864.6600 Osmotic fragility test.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 864.6600, § 864.6600 Osmotic fragility test, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89354
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Full text
(a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions.
(b) Classification. Class I (general controls). This device 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.