PTJ

Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

Product code

PTJ

Device name

Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

Device class

Class 2

21 CFR

21 CFR 866.1640

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

FDA classification definition

Qualitative detection of carbapenemase enzymes in pure colonies of Enterobacteriaceae and Pseudomonas aeruginosa that have elevated MIC values to any Carbapenem

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-06-04.

1 summaries are archived here for direct download.