21 CFR 866.2050 — Phages, Staphylococcal Typing, All Types
Microbiology (MI) · Part 866 Subpart C—Microbiology Devices · § 866.2050
Identification
A staphylococcal typing bacteriophage is a device consisting of a bacterial virus intended for medical purposes to identify pathogenic staphylococcal bacteria through use of the bacteria's susceptibility to destruction by the virus. Test results are used principally for the collection of epidemiological information.
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 |
|---|---|---|---|---|
| GTL | Phages, Staphylococcal Typing, All Types | 1 | 0 | |
| OUS | Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt | 1 | 2 | 3rd Party |
