Title 21: Food and Drugs
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/ PART 866 - IMMUNOLOGY AND MICROBIOLOGY DEVICES
/ Subpart C - Microbiology Devices / § 866.2390 Transport culture medium.
§ 866.2390 Transport culture medium.
(a) Identification. A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.
(b) Classification. Class I (general controls).