ROMA

GUDID 00869164000024

ROMA (HE4 EIA + ARCHITECT CA125II) Software disk

Fujirebio Diagnostics, Inc.

Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD
Primary Device ID00869164000024
NIH Device Record Key3fc2e098-063a-4821-8ce9-07d7c013dedb
Commercial Distribution StatusIn Commercial Distribution
Brand NameROMA
Version Model Number404-10US
Company DUNS048524263
Company NameFujirebio Diagnostics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9999999999
Emailxx@xx.xxx
Phone9999999999
Emailxx@xx.xxx
Phone9999999999
Emailxx@xx.xxx
Phone9999999999
Emailxx@xx.xxx
Phone9999999999
Emailxx@xx.xxx
Phone9999999999
Emailxx@xx.xxx
Phone9999999999
Emailxx@xx.xxx
Phone9999999999
Emailxx@xx.xxx
Phone9999999999
Emailxx@xx.xxx
Phone9999999999
Emailxx@xx.xxx
Phone9999999999
Emailxx@xx.xxx
Phone9999999999
Emailxx@xx.xxx
Phone9999999999
Emailxx@xx.xxx
Phone9999999999
Emailxx@xx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
GS100869164000024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ONXOvarian Adnexal Mass Assessment Score Test System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-19

Devices Manufactured by Fujirebio Diagnostics, Inc.

00869164000055 - Serodia TP-PA Kits2023-12-14 100 test kit
00869164000062 - Serodia TP-PA Kits2023-12-14 220 test kits
00869164000079 - Emit Cyclosporine Sample2023-12-14
00869164000048 - Lumipulse G B-Amyloid Ratio (1-42/1-40) Calculator Tool2022-03-22 Software
00869164000000 - MESOMARK2018-07-06
00869164000017 - Lumipulse G ROMA2018-07-06 Software Disk
00869164000024 - ROMA2018-07-06ROMA (HE4 EIA + ARCHITECT CA125II) Software disk
00869164000024 - ROMA2018-07-06 ROMA (HE4 EIA + ARCHITECT CA125II) Software disk

Trademark Results [ROMA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ROMA
ROMA
98352814 not registered Live/Pending
Yazdanfar, Navid
2024-01-11
ROMA
ROMA
98302244 not registered Live/Pending
Jeremy Lande
2023-12-06
ROMA
ROMA
98081835 not registered Live/Pending
Stewart, D'Shawn A
2023-07-12
ROMA
ROMA
97733844 not registered Live/Pending
Elite Gold Ltd.
2022-12-28
ROMA
ROMA
97213291 not registered Live/Pending
Elite Gold Ltd
2022-01-11
ROMA
ROMA
88723683 not registered Live/Pending
FABRICA DE JABON LA CORONA S.A. DE C.V.
2019-12-11
ROMA
ROMA
88362815 not registered Live/Pending
Vivid Robotics, Inc
2019-03-29
ROMA
ROMA
88033899 not registered Dead/Abandoned
SE7VEN, LLC.
2018-07-11
ROMA
ROMA
87908119 5595818 Live/Registered
Art Van Furniture, LLC
2018-05-04
ROMA
ROMA
87219470 not registered Live/Pending
Karen Day Roma
2016-10-28
ROMA
ROMA
87079858 not registered Dead/Abandoned
FABRICA DE JABON LA CORONA S.A. DE C.V.
2016-06-22
ROMA
ROMA
86805503 not registered Dead/Abandoned
V-Moda, LC
2015-10-30

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