QZX — Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing Class II
FDA product code QZX covers "Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing", a Class II medical device regulated under 21 CFR 866.1650. Submissions are reviewed by the Microbiology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QZX
- Device Class
- Class II
- Regulation Number
- 866.1650
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
Processing device that includes associated reagents, when applicable, that is intended to recover microbes from positive blood cultures for inoculum preparation. The prepared inoculum is intended for subsequent use in antimicrobial susceptibility testing.