| Primary Device ID | 15420045500020 |
| NIH Device Record Key | 6a4529dd-4754-4556-a120-2a20b57360db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Selenia Dimensions C-View Software |
| Version Model Number | C-View |
| Company DUNS | 139534114 |
| Company Name | Hologic, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| 15420045517585 - DIGITAL DIAGNOSTICS SYSTEM | 2025-04-11 Computer to operate the Genius™ Review Station. |
| 15420045516991 - Aptima® | 2025-03-24 Aptima® SARS-CoV-2 Assay, 100 test, box 1 of 2 (2°C to 8°C box). |
| 15420045517004 - Aptima® | 2025-03-24 Aptima® SARS-CoV-2 Assay, 100 test, box 2 of 2 (15°C to 30°C box). |
| 15420045517035 - Aptima® | 2025-03-24 Aptima® SARS-CoV-2 Assay Controls Kit. |
| 15420045517059 - Aptima® | 2024-12-27 Aptima® BV assay, 250 test, box 1 of 2 (2°C to 8°C box). The Aptima® BV assay is an in vitro nucleic acid amplification test |
| 15420045517066 - Aptima® | 2024-12-27 Aptima® BV assay, 250 test, box 2 of 2 (15°C to 30°C box). The Aptima® BV assay is an in vitro nucleic acid amplification te |
| 15420045517073 - Aptima® | 2024-12-27 Aptima® CV/TV assay, 250 test, box 1 of 2 (2°C to 8°C box). The Aptima® CV/TV assay is an in vitro nucleic acid amplificatio |
| 15420045517080 - Aptima® | 2024-12-27 Aptima® CV/TV assay, 250 test, box 2 of 2 (15°C to 30°C box). The Aptima® CV/TV assay is an in vitro nucleic acid amplificat |