PMY — System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony Class II

FDA Device Classification

Classification Details

Product Code: PMY
Device Class: Class II
Regulation Number: 866.1640
Submission Type
Review Panel: MI
Medical Specialty: Microbiology
Implant: No

Definition

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

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K191288	opgen	Acuitas AMR Gene Panel	September 30, 2021
K190275	genepoc	GenePOC Carba	May 10, 2019
K152614	cepheid	Xpert Carba-R	March 7, 2016