PTJ
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Medical specialty
- Microbiology
- FDA definition
- Qualitative detection of carbapenemase enzymes in pure colonies of Enterobacteriaceae and Pseudomonas aeruginosa that have elevated MIC values to any Carbapenem
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| NG-Test® CTX-M MULTI (K243499) | Ng Biotech | 2025-06-04 |
| NG-Test CARBA 5 (K191889) | Ng Biotech | 2019-10-02 |
| RAPIDEC CARBA NP (K162385) | Biomerieux S.A. | 2017-04-27 |
Track PTJ automatically
Every clearance here is in the API, with alerts when new ones post.