Primary Device ID | 00869164000017 |
NIH Device Record Key | c9822222-c641-4a3b-9e7e-2546cecacd47 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Lumipulse G ROMA |
Version Model Number | CL0004 |
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 | 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 | true |
OTC Over-The-Counter | false |
Phone | 9999999999 |
xx@xx.xxx | |
Phone | 9999999999 |
xx@xx.xxx | |
Phone | 9999999999 |
xx@xx.xxx | |
Phone | 9999999999 |
xx@xx.xxx | |
Phone | 9999999999 |
xx@xx.xxx | |
Phone | 9999999999 |
xx@xx.xxx | |
Phone | 9999999999 |
xx@xx.xxx | |
Phone | 9999999999 |
xx@xx.xxx | |
Phone | 9999999999 |
xx@xx.xxx | |
Phone | 9999999999 |
xx@xx.xxx | |
Phone | 9999999999 |
xx@xx.xxx | |
Phone | 9999999999 |
xx@xx.xxx | |
Phone | 9999999999 |
xx@xx.xxx | |
Phone | 9999999999 |
xx@xx.xxx |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00869164000017 [Primary] |
ONX | Ovarian Adnexal Mass Assessment Score Test System |
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 | 2016-09-19 |
00869164000086 - Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio | 2024-11-12 Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio |
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 | 2022-03-22 Software |
00869164000000 - MESOMARK | 2018-07-06 |
00869164000017 - Lumipulse G ROMA | 2018-07-06Software Disk |
00869164000017 - Lumipulse G ROMA | 2018-07-06 Software Disk |
00869164000024 - ROMA | 2018-07-06 ROMA (HE4 EIA + ARCHITECT CA125II) Software disk |