| Primary Device ID | 00613745003481 |
| NIH Device Record Key | 8deeddf0-e009-4ba0-ba29-595bbaef22be |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GenDx-AMPure XP - AMPure beads and elution buffer (5 ml) |
| Version Model Number | 5343653 |
| Company DUNS | 940425333 |
| Company Name | Genbio |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 8585929300 |
| orders@genbio.com | |
| Phone | 8585929300 |
| orders@genbio.com | |
| Phone | 8585929300 |
| orders@genbio.com | |
| Phone | 8585929300 |
| orders@genbio.com | |
| Phone | 8585929300 |
| orders@genbio.com | |
| Phone | 8585929300 |
| orders@genbio.com | |
| Phone | 8585929300 |
| orders@genbio.com | |
| Phone | 8585929300 |
| orders@genbio.com | |
| Phone | 8585929300 |
| orders@genbio.com | |
| Phone | 8585929300 |
| orders@genbio.com | |
| Phone | 8585929300 |
| orders@genbio.com | |
| Phone | 8585929300 |
| orders@genbio.com | |
| Phone | 8585929300 |
| orders@genbio.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613745003481 [Primary] |
| MZI | Test, Qualitative, For Hla, Non-Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-05 |
| Device Publish Date | 2025-12-27 |