Definition: Reagents Intended For In Vitro Diagnostic Use As A Panel For Qualitative Identification Of Cell Populations By Multiparameter Immunophenotyping On A Flow Cytometer. These Reagents Are Used As An Aid In The Differential Diagnosis Of Hematologically Ab
| Device Type ID | 2450 |
| Device Name | Flow Cytometric Test System For Hematopoietic Neoplasms |
| Physical State | Monoclonal And Polyclonal Antibody Cocktails In Panels, Accessory Reagents Including Software And Beads Used For Analysis And Acquisition Of Data. |
| Technical Method | These Reagents Provide Multiparameter, Qualitative Results For The Cluster Of Differentiation (CD) Parameters. |
| Target Area | Whole Blood, Bone Marrow, And Lymph Node Specimens. |
| Regulation Description | Flow Cytometric Test System For Hematopoietic Neoplasms. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.7010 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PWD |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2450 |
| Device | Flow Cytometric Test System For Hematopoietic Neoplasms |
| Product Code | PWD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Flow Cytometric Test System For Hematopoietic Neoplasms. |
| CFR Regulation Number | 864.7010 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BECKMAN COULTER | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |