PRH — Positive Blood Culture Identification And Ast Kit Class II
FDA product code PRH covers "Positive Blood Culture Identification And Ast Kit", a Class II medical device regulated under 21 CFR 866.1650. 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
- PRH
- Device Class
- Class II
- Regulation Number
- 866.1650
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
Fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) kit intended for simultaneous detection and identification of multiple microbial targets.