DeviceClearance

Product code NQX— Microbiology

ARIES MRSA Assay

Classification name
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Device class
Class 2
Regulation
21 CFR 866.1640
Advisory panel
Microbiology
Total cleared
24
First cleared
Most recent

FDA classification definition

“A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of MRSA colonization status for the prevention and control of MRSA infections in healthcare settings.”

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

Market context for product code NQX

FDA has cleared 24 devices under product code NQX between 2004 and 2024, filed by 12 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 NQX

Recent clearances under product code NQX

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