PTJ — Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates Class II
FDA product code PTJ covers "Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates", a Class II medical device regulated under 21 CFR 866.1640. 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
- PTJ
- Device Class
- Class II
- Regulation Number
- 866.1640
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
Qualitative detection of carbapenemase enzymes in pure colonies of Enterobacteriaceae and Pseudomonas aeruginosa that have elevated MIC values to any Carbapenem