← FDA Medical Device Classifications
Leishmania Spp. Antigen Detection Assay
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
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown