21 C.F.R. · Food and Drugs
21 C.F.R. § 864.6550

Occult blood test.

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21 C.F.R. § 864.6550 — Occult blood test.

§ 864.6550 Occult blood test. (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. [45 FR 60606, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]

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The regulatory text of 21 C.F.R. § 864.6550 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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