PMY · Class II · 21 CFR 866.1640

FDA Product Code PMY: System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-susceptible Gram Negative Organism, Colony

To Detect The Presence Of Genetic Markers Of Antimicrobial Resistance By Testing Isolated Bacterial Colonies Using Nucleic Acid Amplification Technology.

Leading manufacturers include Cepheid, Genepoc, Inc. and Opgen, Inc..

3
Total
3
Cleared
379d
Avg days
2016
Since

FDA 510(k) Cleared System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-susceptible Gram Negative Organism, Colony Devices (Product Code PMY)

3 devices
1–3 of 3
Cleared Sep 30, 2021
Acuitas AMR Gene Panel
K191288
Opgen, Inc.
Microbiology · 871d
Cleared May 10, 2019
GenePOC Carba
K190275
Genepoc, Inc.
Microbiology · 91d
Cleared Mar 07, 2016
Xpert Carba-R
K152614
Cepheid
Microbiology · 175d

About Product Code PMY - Regulatory Context