21 CFR 866.2410 — Culture Media, For Isolation Of Pathogenic Neisseria
Microbiology (MI) · Part 866 Subpart C—Microbiology Devices · § 866.2410
Identification
A culture medium for pathogenic Neisseria spp. is a device that consists primarily of liquid or solid biological materials used to cultivate and identify pathogenic Neisseria spp. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Neisseria, such as epidemic cerebrospinal meningitis, other meningococcal disease, and gonorrhea, and also provides epidemiological information on these microorganisms.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 2 | 83 | 3rd Party |
