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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ivd offered as ldt, first marketed before may 6, 2024, not modified beyond scope described in preamble to ldt final rule
Definition Currently marketed in vitro diagnostic products (IVDs) offered as laboratory developed tests (LDTs) that were first marketed prior to May 6, 2024, and not modified following that date or not modified beyond the scope described in section V.B.3 of the preamble to the LDT Final Rule (89 FR 37286).
Product CodeSCE
Device Class Not Classified

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