KZC · Manual Colony Counter
Microbiology · 21 CFR 866.2180 · Class 1
Overview
| Product Code | KZC |
|---|---|
| Device Name | Manual Colony Counter |
| Regulation | 21 CFR 866.2180 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
| GMP Exempt | Yes |
Identification
A manual colony counter is a device intended for medical purposes that consists of a printed grid system superimposed on an illuminated screen. Petri plates containing bacterial colonies to be counted are placed on the screen for better viewing and ease of counting. 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. The device is also exempt from the good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
