Flow Cytometry Calibrator
Device Code: 2871
Product Code(s):
PDX 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 Cyto
Device Classification Information
| Device Type ID | 2871 |
| Device Name | Flow Cytometry Calibrator |
| Physical State | Beads For Performing Absolute Counts Of Cells In Suspension By Flow Cytometry Beads For Standardizing Flow Cytometers Beads That Are Used To Calibrate Fluorescence Intensity To Quantify Ligand Binding Or Fluorogenic Assays Performed By Flow Cytometry |
| Technical Method | Bead Associated Fluorescence Or Scattered Light Is Used To Determine The Number Of Other Particles In Solution Ratio-metrically And To Calibrate Fluorescence Intensity Scales On A Flow Cytometer To Standardize Measures. |
| Target Area | Peripheral Blood |
| Regulation Description | Automated Differential Cell Counter. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 864.5220 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PDX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 2871 |
| Device | Flow Cytometry Calibrator |
| Product Code | PDX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Automated Differential Cell Counter. |
| CFR Regulation Number | 864.5220 [🔎] |
TPLC Last Update: 2019-04-02 20:20:21