OUZ — Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids Class I
FDA product code OUZ covers "Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids", a Class I medical device regulated under 21 CFR 866.3870. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OUZ
- Device Class
- Class I
- Regulation Number
- 866.3870
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
Detection of Leishmania species in skin lesions.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K081868 | u.s. army medical research institute of infectious | SMART LEISH, MODEL LGM1-050 | May 25, 2011 |