CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES > SUBPART C—Microbiology Devices (§866.2050 to §866.2900) > 866.2480—Quality control kit for culture media.

866.2480—Quality control kit for culture media.

(a) Identification. A quality control kit for culture media is a device that consists of paper discs (or other suitable materials), each impregnated with a specified, freeze-dried, viable microorganism, intended for medical purposes to determine if a given culture medium is able to support the growth of that microorganism. 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). 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.

Code of Federal Regulations

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 FR 38791, July 25, 2001]