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U.S. Department of Health and Human Services

Product Classification
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Device nucleic amplification assays for the detection of leishmania nucleic acids
Regulation Description Trypanosoma spp. serological reagents.
Definition Detection of Leishmania species in skin lesions.
Physical State In vitro diagnostic kit
Technical Method Nucleic Acid Amplification assay containing probes and primers
Target Area suspected skin ulcer or skin lesion
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeOUZ
Premarket Review Office of In Vitro Diagnostics (OHT7)
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
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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