| Primary Device ID | 15420045512474 |
| NIH Device Record Key | 9e9aa535-f885-4da8-b35b-5d205d952ffb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GENIUS AI DETECTION |
| Version Model Number | GENIUS AI DETECTION SOFTWARE |
| Company DUNS | 139534114 |
| Company Name | Hologic, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| 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 |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15420045512474 [Primary] |
| OTE | Digital breast tomosynthesis |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-09 |
| Device Publish Date | 2020-12-01 |
| 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 |
| 15420045506411 - ATEC | 2024-10-24 |
| 15420045506428 - ATEC | 2024-10-24 |
| 15420045516144 - Fluent Pro Procedure Kit | 2024-10-23 The Fluent Pro Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hy |
| 15420045516113 - Fluent Pro Waste Bag | 2024-10-23 The Fluent Pro Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hy |