| Primary Device ID | 00884999048959 |
| NIH Device Record Key | 47d76484-da34-432f-872b-c3f695cc78c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alinity mp |
| Version Model Number | 09N65-005 |
| Catalog Number | 09N65-005 |
| Company DUNS | 878263359 |
| Company Name | ABBOTT MOLECULAR INC. |
| 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 | 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 |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884999048959 [Primary] |
| JQW | STATION, PIPETTING AND DILUTING, FOR CLINICAL USE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-03 |
| Device Publish Date | 2024-04-25 |
| 00884999048911 | Alinity mp System |
| 00884999048980 | 09N65-008 |
| 00884999048959 | Alinity mp SurePath Holder, Replacement |
| 00884999048942 | Alinity mp Exception Rack, Replacement |
| 00884999048935 | Alinity mp Vial Input Rack Replacement |
| 00884999048928 | 09N65-002 |
| 00884999051720 | Alinity mp Well Plate |
| 00884999051515 | Alinity mp Well Plate Input Rack |
| 00884999051508 | Alinity mp Tube Input Rack |
| 00884999048973 | Alinity mp Reagent Addition Assembly |