21 C.F.R. § 866.2170 Automated colony counter.
Title 21 - Food and Drugs
(a) Identification. An automated colony counter is a mechanical device intended for medical purposes to determine the number of bacterial colonies present on a bacteriological culture medium contained in a petri plate. The number of colonies counted is used in the diagnosis of disease as a measure of the degree of bacterial infection. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §866.9. [47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25045, June 12, 1989; 66 FR 38790, July 25, 2001]
Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart C—Microbiology Devices
§ 866.2170 Automated colony counter.
