Primary Device ID | 00869164000024 |
NIH Device Record Key | 3fc2e098-063a-4821-8ce9-07d7c013dedb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ROMA |
Version Model Number | 404-10US |
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 | 00869164000024 [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 | 2018-07-06 Software Disk |
00869164000024 - ROMA | 2018-07-06ROMA (HE4 EIA + ARCHITECT CA125II) Software disk |
00869164000024 - ROMA | 2018-07-06 ROMA (HE4 EIA + ARCHITECT CA125II) Software disk |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ROMA 98527371 not registered Live/Pending |
Eric McLendon 2024-04-30 |
ROMA 98352814 not registered Live/Pending |
Yazdanfar, Navid 2024-01-11 |
ROMA 98302244 not registered Live/Pending |
Jeremy Lande 2023-12-06 |
ROMA 98081835 not registered Live/Pending |
Stewart, D'Shawn A 2023-07-12 |
ROMA 97733844 not registered Live/Pending |
Elite Gold Ltd. 2022-12-28 |
ROMA 97213291 not registered Live/Pending |
Elite Gold Ltd 2022-01-11 |
ROMA 88723683 not registered Live/Pending |
FABRICA DE JABON LA CORONA S.A. DE C.V. 2019-12-11 |
ROMA 88362815 not registered Live/Pending |
Vivid Robotics, Inc 2019-03-29 |
ROMA 88033899 not registered Dead/Abandoned |
SE7VEN, LLC. 2018-07-11 |
ROMA 87908119 5595818 Live/Registered |
Art Van Furniture, LLC 2018-05-04 |
ROMA 87219470 not registered Live/Pending |
Karen Day Roma 2016-10-28 |
ROMA 87079858 not registered Dead/Abandoned |
FABRICA DE JABON LA CORONA S.A. DE C.V. 2016-06-22 |