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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 864 - Hematology and Pathology Devices |
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Subpart G - Manual Hematology Devices |
§ 864.6550 - Occult blood test.
Latest version.
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§ 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 (performance standards). 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]