QBQ · System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture
Microbiology · 21 CFR 866.2560 · Class 1
Overview
| Product Code | QBQ |
|---|---|
| Device Name | System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture |
| Regulation | 21 CFR 866.2560 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
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.
Classification Rationale
Class I. With the exception of automated blood culturing system devices that are used in testing for bacteria, fungi, and other microorganisms in blood and other normally sterile body fluids, this device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K172412 | BacterioScan 216Dx System | Bacterioscan, Inc. | May 1, 2018 | SESE |
Top Applicants
- Bacterioscan, Inc. — 1 clearance
