Platelet Rich Plasma Testing (pH, blood cell count, platelet count/recovery/concentration factor/p-selectin expression/stress response/aggregation)


Laboratory Test Request Description

MULTIPLE TESTING
Cell Biology Laboratory needed for testing Platelet Rich Plasma - PRP 510(k) filing to include:
- pH (Note: pH of concentrated platelets should not be less than 6.2)
- Blood cell count (RBC, WBC)
- Platelet count
- Platelet recovery (Note: lower bound of the 95% confidence interval for mean platelet recovery should be at least 50%)
- Platelet concentration factor
- P-selectin expression on platelets (on resting and ADP activated platelets)
- Hypotonic stress response
- Platelet aggregation (collagen)


INFORMATION

Number: 23-00616

Industry: Life Sciences



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