Definition: Detection Of Leishmania Species In Skin Lesions.
| Device Type ID | 3541 |
| Device Name | Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids |
| 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 Description | Trypanosoma Spp. Serological Reagents. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | 510(k) |
| CFR Regulation Number | 866.3870 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OUZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |