Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids
The Nucleic Amplification Assays for the Detection of Leishmania Nucleic Acids (product code OUZ) is a Class 1 in vitro diagnostic test for the detection of Leishmania species in skin lesions. It uses nucleic acid amplification techniques to identify Leishmania DNA directly from clinical specimens, supporting the diagnosis of leishmaniasis. As an FDA Class 1 device under regulation 866.3870, it is subject only to general controls and falls within the Microbiology specialty. The device is not an implant and is not life-sustaining.
Research product code OUZ in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- OUZ
- Device Class
- FDA class 1
- Regulation Number
- 866.3870
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
Detection of Leishmania species in skin lesions.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K081868 | SMART LEISH, MODEL LGM1-050 | May 25, 2011 | Substantially Equivalent | U.S. Army Medical Research Institute of Infectious |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.