FDA Product Code
FDA Product Code PQA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.3975
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260021 | cobas® BV/CV | Roche Molecular Systems, Inc. | 2026-07-16 | Traditional | PDF ↗ |
| K243725 | BD Vaginal Panel | Becton, Dickinson and Company | 2024-12-19 | Special | PDF ↗ |
| K243345 | Aptima BV Assay; Aptima CV/TV Assay | Hologic, Inc. | 2024-11-25 | Special | PDF ↗ |
| K231381 | Xpert Xpress MVP; GeneXpert Xpress System | Cepheid | 2023-10-19 | Dual Track | PDF ↗ |
| K223653 | BD Vaginal Panel | Becton, Dickinson and Company | 2023-03-06 | Traditional | PDF ↗ |
| K221160 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | Cepheid | 2022-06-07 | Special | PDF ↗ |
| K212213 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | Cepheid | 2022-02-09 | Traditional | PDF ↗ |
| K201017 | BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit | Geneohm Sciences Canada, Inc. (Bd Life Sciences) | 2021-10-18 | Traditional | PDF ↗ |
| K191957 | BD MAX Vaginal Panel | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2019-10-21 | Traditional | PDF ↗ |
| K190452 | Aptima BV Assay | Hologic, Inc. | 2019-05-23 | Traditional | PDF ↗ |
| K190472 | Aptima CV/TV Assay | Hologic, Inc. | 2019-05-16 | Traditional | PDF ↗ |
| DEN160001 | BD MAX Vaginal Panel, BD MAX Instrument | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2016-10-28 | Direct | — |
Product code PQA · Class II · Microbiology. Data: openFDA.