15mL FDA-510(k) Cleared Made-in-the-USA PRP Tube PL
Three 15mL PRP tubes with standard density, conforming to FDA-510(k) standards.
Specifications
- Specifications
- Key Features – 15cc Protocol •FDA-Cleared, Class II Medical Device, 510(k)-Cleared •Integrated anticoagulant- No ACD-A needed •Industry leader in three critical areas: -Reproducible concentrations from consistent platelet recovery/85+% -Balanced pH -99% removal of RBCs •Vacutainer system for simplified blood collectionical Device, 510(k)-Cleared •Compatible with existing 30mm diameter centrifuges •Single spin 15mL’s of whole blood -3mL’s high concentration PRP -5mL’s mid concentration PRP
- Test results
- 510(k) equivalence study conducted and the following mean results were achieved: •Platelet Concentration Factor at 0 Hours = 4.1 – 4.5x baseline •Platelet Concentration Factor at 1 Hour = 4.5 – 4.8x baseline •Platelet Recovery % at 1 Hour = 61% •RBC at 0 Hours = 0.01 •RBC at 4 Hours = 0.01 •pH at 0 Hours = 7.5 •pH at 4 Hours = 7.65 •Platelet Activation (Resting) at 0 Hours = 10.2% •Platelet Activation (Stimulated ADP) at 0 Hours = 96.3% •Platelet Aggregation at 0 Hours = 96.1% •Platelet Aggregation at 4 Hours = 95.8% •HCT at 0 Hours = 0.01% •HCT at 4 Hours = 0.01% •WBC at 0 Hours = 0.6 •WBC at 4 Hours = 0.6
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