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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State In vitro diagnostic kit
Technical Method May include immunochromatographic assays, enzyme linked immunoassays, or other in vitro diagnostic methods to detect antigens from Leishmania spp.
Target Area Clinical specimens from patients suspected of infection with Leishmania spp.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePIT
Premarket Review Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3870
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons