21 CFR 864.8540
§ 864.8540 Red cell lysing reagent.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.8540, § 864.8540 Red cell lysing reagent, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89402
- Permanent ID
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Full text
(a) Identification. A red cell lysing reagent is a device used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells.
(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.