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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device leishmania spp. antigen detection assay
Regulation Description Trypanosoma spp. serological reagents.
Definition An in vitro diagnostic test for the detection of Leishmania spp. antigens to aid in the diagnosis of Leishmania spp. infection.
Product CodePIT
Regulation Number 866.3870
Device Class 1

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