| Primary Device ID | 04987270230954 |
| NIH Device Record Key | 670ef1be-e9c0-421b-8e13-d4b7dbd56493 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lumipulse G Prolactin Calibrators |
| Version Model Number | 230954 |
| Company DUNS | 710873907 |
| Company Name | FUJIREBIO 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 | true |
| Device Combination Product | false |
| Single Use | false |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Right side up with care; no vibration |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Right side up with care; no vibration |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |