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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device whole blood pre-treatment t-cell enrichment reagent
Definition The reagent is for the pre-treatment of whole blood prior to lymphocyte separation. The reagent aids in the removal of selected white blood cells from whole blood stored at room temperature (18-25°C).
Product CodeORL
Device Class 3

MDR Year MDR Reports MDR Events
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Retraction Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
Abrasion 1 1

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