Definition: To Prepare Cell Concentrate And/or Plasma Concentrate By Separating Cells Through Centrifugation. Contraindications - Labeling Warnings And Precautions: The Safety And Effectiveness Of This Device For In Vivo Indications For Use Has Not Been Establis
| Device Type ID | 2237 |
| Device Name | Centrifuge For Preparation Of Cell Concentrate And/or Plasma Concentrate |
| Physical State | Centrifuge, Process Disposable And System Accessories |
| Technical Method | Uses Centrifugation To Separate Cells Based On Cell Density |
| Target Area | Bone Marrow And Peripheral Blood Asprirate |
| Regulation Description | General Purpose Laboratory Equipment Labeled Or Promoted For A Specific Medical Use. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 862.2050 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | QBV |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |