21 CFR 864.6550
§ 864.6550 Occult blood test.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 864.6550, § 864.6550 Occult blood test, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89353
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Full text
(a) Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)
(b) Classification. Class II (special controls). A control intended for use with an occult blood test 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.