| Primary Device ID | 04987270234273 |
| NIH Device Record Key | 06a68af9-742a-4687-95d8-302ad7cd990b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lumipulse G CA125II Immunoreaction Cartridges |
| Version Model Number | 234273 |
| Company DUNS | 710873907 |
| Company Name | FUJIREBIO 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 | 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 |
| Phone | 610-240-3800 |
| customersupport@fdi.com |
| Device Size Text, specify | 0 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04987270234273 [Primary] |
| LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-16 |