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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
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


Premarket Reviews
ManufacturerDecision
INBIOS INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 1

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