Product code PDX

Device name

Flow Cytometry Calibrator

Medical specialty

Hematology

Device class

2

Regulation number

864.5220

Review panel

IM

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset