21 C.F.R. § 866.2900 Microbiological specimen collection and transport device.
Title 21 - Food and Drugs
(a) Identification. A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms. (b) Classification. Class I (general controls).
Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart C—Microbiology Devices
§ 866.2900 Microbiological specimen collection and transport device.
