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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ldt, non-molecular antisera for rare rbc antigens when there is no alternative ivd
Definition Non-molecular antisera laboratory developed tests (LDTs) for rare red blood cell (RBC) antigens when manufactured and performed by blood establishments, including transfusion services and immunohematology laboratories, and when there is no alternative in vitro diagnostic product (IVD) available to meet the patient's need for a compatible blood transfusion within the scope described in Section V.B.3 of the preamble to the Final LDT Rule (89 FR 37286).
Product CodeSCK
Device Class Not Classified

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