PRH
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Positive Blood Culture Identification And Ast Kit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1650
- Medical specialty
- Microbiology
- FDA definition
- Fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) kit intended for simultaneous detection and identification of multiple microbial targets.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Accelerate Pheno System, Accelerate PhenoTest BC Kit (K192665) | Accelerate Diagnostics, Inc. | 2020-09-15 |
| Accelerate Pheno system, Accelerate Phenotest BC Kit (DEN160032) | Accelerate Diagnotics | 2017-02-23 |
Track PRH automatically
Every clearance here is in the API, with alerts when new ones post.