QBH — Lower Respiratory Microbial Nucleic Acid Detection System Class II
FDA product code QBH covers "Lower Respiratory Microbial Nucleic Acid Detection System", a Class II medical device regulated under 21 CFR 866.3985. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QBH
- Device Class
- Class II
- Regulation Number
- 866.3985
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.