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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ldt, unmet need within an integrated healthcare system
Definition Laboratory developed tests (LDTs) manufactured and performed by a laboratory integrated within a healthcare system to meet an unmet need of patients receiving care within the same healthcare system as described in section V.B.3 of the preamble to the LDT Final Rule (89 FR 37286).
Product CodeSCF
Device Class Not Classified

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