PMY
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Medical specialty
- Microbiology
- FDA definition
- To detect the presence of genetic markers of antimicrobial resistance by testing isolated bacterial colonies using nucleic acid amplification technology.
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| Record | Firm | Date |
|---|---|---|
| Acuitas AMR Gene Panel (K191288) | Opgen, Inc. | 2021-09-30 |
| GenePOC Carba (K190275) | Genepoc, Inc. | 2019-05-10 |
| Xpert Carba-R (K152614) | Cepheid | 2016-03-07 |
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