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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, not an ldt or under a targeted enforcement discretion policy described in preamble to ldt final rule
Definition In vitro diagnostic products (IVDs) offered as laboratory developed tests (LDTs) that are not designed, manufactured, and used within a single laboratory, are within the scope of the phaseout policy and are not subject to a targeted enforcement discretion policy described in the preamble to the LDT Final Rule (89 FR 37286).
Product CodeSCI
Device Class Not Classified

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