21 CFR 866.2560 — Monitor, Microbial Growth
Microbiology (MI) · Part 866 Subpart C—Microbiology Devices · § 866.2560
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JTA | Monitor, Microbial Growth | 1 | 11 | |
| LJF | Device, Antimicrobial Drug Removal | 1 | 4 | |
| MDB | System, Blood Culturing | 1 | 67 | 3rd Party |
| MZC | System, Detection, Bacterial, For Platelet Transfusion Products | 1 | 0 | |
| QBQ | System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture | 1 | 1 |
