PDX — Flow Cytometry Calibrator Class II
FDA product code PDX covers "Flow Cytometry Calibrator", a Class II medical device regulated under 21 CFR 864.5220. Submissions are reviewed by the Hematology panel.
Classification Details
- Product Code
- PDX
- Device Class
- Class II
- Regulation Number
- 864.5220
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Hematology
- Implant
- No
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.