Lumipulse G ROMA

GUDID 00869164000017

Software Disk

Fujirebio Diagnostics, Inc.

Laboratory instrument/analyser application software IVD
Primary Device ID00869164000017
NIH Device Record Keyc9822222-c641-4a3b-9e7e-2546cecacd47
Commercial Distribution StatusIn Commercial Distribution
Brand NameLumipulse G ROMA
Version Model NumberCL0004
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
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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
GS100869164000017 [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 ROMA2018-07-06Software Disk
00869164000017 - Lumipulse G ROMA2018-07-06 Software Disk
00869164000024 - ROMA2018-07-06 ROMA (HE4 EIA + ARCHITECT CA125II) Software disk

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