Definition: An In Vitro Diagnostic Test For The Detection Of Leishmania Spp. Antigens To Aid In The Diagnosis Of Leishmania Spp. Infection.
| Device Type ID | 3567 |
| Device Name | Leishmania Spp. Antigen Detection Assay |
| 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 Description | Trypanosoma Spp. Serological Reagents. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3870 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | PIT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3567 |
| Device | Leishmania Spp. Antigen Detection Assay |
| Product Code | PIT |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Trypanosoma Spp. Serological Reagents. |
| CFR Regulation Number | 866.3870 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
INBIOS INTERNATIONAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |