PMY

System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony

Product code

PMY

Device name

System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony

Device class

Class 2

21 CFR

21 CFR 866.1640

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

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

FDA classification definition

To detect the presence of genetic markers of antimicrobial resistance by testing isolated bacterial colonies using nucleic acid amplification technology.

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