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e-CFR data is current as of September 21, 2020

Title 21Chapter ISubchapter HPart 864Subpart G → §864.6550


Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart G—Manual Hematology Devices


§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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