21 CFR 866.2850 — Reader, Zone, Automated
Microbiology (MI) · Part 866 Subpart C—Microbiology Devices · § 866.2850
Identification
An automated zone reader is a mechanical device intended for medical purposes to measure zone diameters of microbial growth inhibition (or exhibition), such as those observed on the surface of certain culture media used in disc-agar diffusion antimicrobial susceptibility tests. The device aids in decisionmaking respecting the treatment of disease.
Classification Rationale
Class I (general controls).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KZK | Reader, Zone, Automated | 1 | 3 | 3rd Party |
