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System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony

FDA product code PMY · 3 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
2016-03-07 – 2021-09-30

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

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