21 C.F.R. § 864.6550 Occult blood test.
Title 21 - Food and Drugs
(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). [45 FR 60606, Sept. 12, 1980]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart G—Manual Hematology Devices
§ 864.6550 Occult blood test.
