POC

System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen

Product code

POC

Device name

System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen

Device class

Class 2

21 CFR

21 CFR 866.1640

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

4 (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 directly from clinical specimens using nucleic acid amplification technology.

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

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-07-02.

1 summaries are archived here for direct download.