Reagent, Leishmanii Serological
Reagent, Leishmaniasis Serological is a serological reagent used in laboratory tests to detect antibodies against Leishmania species in patient serum, supporting the diagnosis of leishmaniasis, a parasitic disease transmitted by sandfly bites that can affect the skin, mucous membranes, or visceral organs. This device is classified as FDA Class 1, the lowest risk category, requiring only general controls. The product code is LOO, regulated under 21 CFR 866.3870, within the Microbiology medical specialty. This device is eligible for third-party 510(k) review.
Basic Information
- Product Code
- LOO
- Device Class
- FDA class 1
- Regulation Number
- 866.3870
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.