PIT
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Leishmania Spp. Antigen Detection Assay
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3870
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
- FDA definition
- An in vitro diagnostic test for the detection of Leishmania spp. antigens to aid in the diagnosis of Leishmania spp. infection.
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| Record | Firm | Date |
|---|---|---|
| CL DETECT RAPID TEST (K141341) | InBios International, Inc. | 2014-11-14 |
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