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

FDA product code POC · 4 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.1640
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2016-06-29 – 2026-07-02

To detect the presence of genetic markers of antimicrobial resistance by testing directly from clinical specimens using nucleic acid amplification technology.

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