21 CFR 866.2170 — Automated Colony Counter
Microbiology (MI) · Part 866 Subpart C—Microbiology Devices · § 866.2170
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.
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
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KZB | Automated Colony Counter | 1 | 1 |
