| Primary Device ID | 00869164000048 |
| NIH Device Record Key | 3b0d7907-9eab-4688-ac05-0efb9c484391 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lumipulse G B-Amyloid Ratio (1-42/1-40) Calculator Tool |
| Version Model Number | CL0012 |
| Company DUNS | 048524263 |
| Company Name | Fujirebio Diagnostics, 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00869164000048 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-22 |
| Device Publish Date | 2022-03-14 |
| 00869164000055 - Serodia TP-PA Kits | 2023-12-14 100 test kit |
| 00869164000062 - Serodia TP-PA Kits | 2023-12-14 220 test kits |
| 00869164000079 - Emit Cyclosporine Sample | 2023-12-14 |
| 00869164000048 - Lumipulse G B-Amyloid Ratio (1-42/1-40) Calculator Tool | 2022-03-22Software |
| 00869164000048 - Lumipulse G B-Amyloid Ratio (1-42/1-40) Calculator Tool | 2022-03-22 Software |
| 00869164000000 - MESOMARK | 2018-07-06 |
| 00869164000017 - Lumipulse G ROMA | 2018-07-06 Software Disk |
| 00869164000024 - ROMA | 2018-07-06 ROMA (HE4 EIA + ARCHITECT CA125II) Software disk |