PDX

Flow Cytometry Calibrator

Product code

PDX

Device name

Flow Cytometry Calibrator

Device class

Class 2

21 CFR

21 CFR 864.5220

Medical specialty

Hematology

Marketing pathway

510(K)

Flag

Third-party review eligible

FDA classification definition

Flow cytometer calibrators are polystyrene or other particles whose defined characteristics (e.g. number, size, scatter or fluorescence intensity) is used to standardize instrumentation or to quantify other particles or analytes measured by flow cytometers.

Definition text from the FDA device classification database (U.S. federal government work, public domain).