QQV — Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry Class II
FDA product code QQV covers "Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry", a Class II medical device regulated under 21 CFR 866.3378. Submissions are reviewed by the Microbiology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QQV
- Device Class
- Class II
- Regulation Number
- 866.3378
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
An automated in vitro diagnostic system to prepare colonies of microorganisms grown on solid culture media from human specimens for qualitative identification and differentiation using matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS).