MESOMARK

GUDID 00869164000000

Fujirebio Diagnostics, Inc.

Mucin-like carcinoma-associated antigen (MCA) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00869164000000
NIH Device Record Keya0e596ca-1ec5-400a-870b-754a0d093c45
Commercial Distribution StatusIn Commercial Distribution
Brand NameMESOMARK
Version Model Number801-905
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-877-861-7246
Emailcustomerservice@fdi.com
Phone1-877-861-7246
Emailcustomerservice@fdi.com
Phone1-877-861-7246
Emailcustomerservice@fdi.com
Phone1-877-861-7246
Emailcustomerservice@fdi.com
Phone1-877-861-7246
Emailcustomerservice@fdi.com
Phone1-877-861-7246
Emailcustomerservice@fdi.com
Phone1-877-861-7246
Emailcustomerservice@fdi.com
Phone1-877-861-7246
Emailcustomerservice@fdi.com
Phone1-877-861-7246
Emailcustomerservice@fdi.com
Phone1-877-861-7246
Emailcustomerservice@fdi.com
Phone1-877-861-7246
Emailcustomerservice@fdi.com
Phone1-877-861-7246
Emailcustomerservice@fdi.com
Phone1-877-861-7246
Emailcustomerservice@fdi.com
Phone1-877-861-7246
Emailcustomerservice@fdi.com
Phone1-877-861-7246
Emailcustomerservice@fdi.com
Phone1-877-861-7246
Emailcustomerservice@fdi.com
Phone1-877-861-7246
Emailcustomerservice@fdi.com
Phone1-877-861-7246
Emailcustomerservice@fdi.com

Device Dimensions

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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100869164000000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OAWCancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic Mesothelioma

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 Date2014-09-17

Devices Manufactured by Fujirebio Diagnostics, Inc.

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 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
00869164000000 - MESOMARK2018-07-06
00869164000017 - Lumipulse G ROMA2018-07-06 Software Disk
00869164000024 - ROMA2018-07-06 ROMA (HE4 EIA + ARCHITECT CA125II) Software disk

Trademark Results [MESOMARK]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MESOMARK
MESOMARK
78530279 3091521 Live/Registered
Fujirebio Diagnostics, Inc.
2004-12-10
MESOMARK
MESOMARK
78421763 3276224 Live/Registered
Fujirebio Diagnostics, Inc.
2004-05-19

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