DeviceClearance

Product code PMY— Microbiology

Acuitas AMR Gene Panel

Classification name
System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
Device class
Class 2
Regulation
21 CFR 866.1640
Advisory panel
Microbiology
Total cleared
3
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code PMY under 21 CFR 866.1640, via openFDA

Market context for product code PMY

FDA has cleared 3 devices under product code PMY between 2016 and 2021, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PMY

Recent clearances under product code PMY

Data sourced from openFDA. This site is unofficial and independent of the FDA.