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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device nucleic amplification assays for the detection of leishmania nucleic acids
Definition Detection of Leishmania species in skin lesions.
Product CodeOUZ
Regulation Number 866.3870
Device Class 1


Premarket Reviews
ManufacturerDecision
U.S. ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS
  SUBSTANTIALLY EQUIVALENT 1

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