# Leishmania Spp. Antigen Detection Assay
> **Product code: PIT** · Class I — Low Risk (general controls) · Microbiology · 21 CFR 866.3870
## Classification
- **FDA Product Code:** PIT
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 866.3870
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Definition

An in vitro diagnostic test for the detection of Leishmania spp. antigens to aid in the diagnosis of Leishmania spp. infection.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PIT)
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