QSN — Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System Class II
FDA product code QSN covers "Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System", a Class II medical device regulated under 21 CFR 866.3988. 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
- QSN
- Device Class
- Class II
- Regulation Number
- 866.3988
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
A qualitative nucleic acid assay that detects and identifies microbial organisms and antimicrobial resistance markers in clinical specimens to aid in the diagnosis of orthopedic infections.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN200066 | biofire diagnostics | BioFire Joint Infection (JI) Panel | April 29, 2022 |