BD BACTEC FXI Culture System
Device Facts
| Record ID | K260213 |
|---|---|
| Device Name | BD BACTEC FXI Culture System |
| Applicant | BD Diagnostic Systems |
| Product Code | MDB · Microbiology |
| Decision Date | May 28, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.2560 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A microbial growth monitor is a device intended for medical purposes that measures the concentration of bacteria suspended in a liquid medium by measuring changes in light scattering properties, optical density, electrical impedance, or by making direct bacterial counts. The device aids in the diagnosis of disease caused by pathogenic microorganisms.
