21 CFR 866.1700 — Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Microbiology (MI) · Part 866 Subpart B—Diagnostic Devices · § 866.1700
Identification
A culture medium for antimicrobial susceptibility tests is a device intended for medical purposes that consists of any medium capable of supporting the growth of many of the bacterial pathogens that are subject to antimicrobial susceptibility tests. The medium should be free of components known to be antagonistic to the common agents for which susceptibility tests are performed in the treatment of disease.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 2 | 40 | 3rd Party |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 2 | 74 | 3rd Party |
| LKA | Culture Media, Antimicrobial Susceptibility Test | 2 | 5 | 3rd Party |
| MJD | Culture Media, Antimycobacteria, Susceptibility Test | 2 | 3 | 3rd Party |
| MJE | Culture Media, Antifungal, Susceptibility Test | 2 | 1 | 3rd Party |
