POC
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
- 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 directly from clinical specimens using nucleic acid amplification technology.
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| Record | Firm | Date |
|---|---|---|
| Xpert Carba-R (K261867) | Cepheid® | 2026-07-02 |
| BD MAX Check-Points CPO (K190613) | Check-Points Health B.V. | 2019-08-29 |
| Xpert Carba-R (K173263) | Cepheid | 2018-01-09 |
| Xpert Carba-R (K160901) | Cepheid | 2016-06-29 |
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Every clearance here is in the API, with alerts when new ones post.