21 CFR 866.2300 — Culture Media, Non-Selective And Non-Differential

Microbiology (MI) · Part 866 Subpart C—Microbiology Devices · § 866.2300

Identification

A multipurpose culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes for the cultivation and identification of several types of pathogenic microorganisms without the need of additional nutritional supplements. Test results aid in the diagnosis of disease and also provide epidemiological information on diseases caused by these microorganisms.

Classification Rationale

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.

Product Codes