| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | Class II | Microbiology | 3 | 2025-05-01 |
| QQX | Respiratory Specimen Nucleic Acid Sars-Cov-2 Test | Class II | Microbiology | 2 | 2025-01-15 |
| NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | Class II | Microbiology | 2 | 2024-12-18 |
| POC | — | — | — | 1 | 2026-07-02 |
| OZN | C. Difficile Toxin Gene Amplification Assay | Class II | Microbiology | 1 | 2025-02-28 |
| NIJ | System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species | Class II | Microbiology | 1 | 2024-11-21 |
| NPR | Test, Factor Ii G20210a Mutations, Genomic Dna Pcr | Class II | Hematology | 1 | 2023-02-15 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-07-02 | K261867 | Xpert Carba-R | POC | — | — |
| 2025-05-01 | K250996 | Xpert Xpress CoV-2/Flu/RSV plus | QOF | Class II | Microbiology |
| 2025-05-01 | K250995 | Xpert Xpress CoV-2/Flu/RSV plus | QOF | Class II | Microbiology |
| 2025-02-28 | K243730 | Xpert C. difficile/Epi | OZN | Class II | Microbiology |
| 2025-01-15 | K242109 | Xpert® Xpress CoV-2 plus (XPRS-COV2-10) | QQX | Class II | Microbiology |
| 2024-12-18 | K243625 | Xpert MRSA/SA SSTI | NQX | Class II | Microbiology |
| 2024-11-21 | K243405 | Xpert vanA | NIJ | Class II | Microbiology |
| 2024-10-25 | K243070 | Xpert® SA Nasal Complete | NQX | Class II | Microbiology |
| 2023-10-13 | K230440 | Xpert® Xpress CoV-2 plus | QQX | Class II | Microbiology |
| 2023-08-17 | K231481 | Xpert Xpress CoV-2/Flu/RSV plus | QOF | Class II | Microbiology |
| 2023-02-15 | K223046 | Xpert® FII & FV | NPR | Class II | Hematology |