Luminex Corporation
FDA 510(k) & PMA Approved Devices — 12 products
Total Devices12
Categories11
Latest Approval2025-06-06
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K243490 | LIAISON PLEX Gram-Positive Blood Culture Assay | PAM | 2025-06-06 | View |
| 510(k) | K243013 | LIAISON PLEX Gram-Negative Blood Culture Assay | PEN | 2025-04-18 | View |
| 510(k) | K240627 | LIAISON PLEX Yeast Blood Culture Assay | PEO | 2024-06-04 | View |
| 510(k) | K233410 | LIAISON PLEX Respiratory Flex Assay | QOF | 2024-03-01 | View |
| 510(k) | K191742 | ARIES MRSA Assay | NQX | 2019-09-25 | View |
| 510(k) | K172402 | ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit | PGX | 2017-10-30 | View |
| 510(k) | K171441 | ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit | OZN | 2017-07-21 | View |
| 510(k) | K163626 | ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit | OZZ | 2017-05-02 | View |
| 510(k) | K162772 | ARIES GBS Assay | NJR | 2016-12-23 | View |
| 510(k) | K161220 | ARIES® Flu A/B & RSV Assay | OCC | 2016-08-02 | View |
| 510(k) | K161495 | ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) | OOI | 2016-06-30 | View |
| 510(k) | K160517 | ARIES System | OOI | 2016-04-12 | View |
No matching devices.