MESOMARK
GUDID 00869164000000
Fujirebio Diagnostics, Inc.
Mucin-like carcinoma-associated antigen (MCA) IVD, kit, enzyme immunoassay (EIA)| Primary Device ID | 00869164000000 |
| NIH Device Record Key | a0e596ca-1ec5-400a-870b-754a0d093c45 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MESOMARK |
| Version Model Number | 801-905 |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-877-861-7246 |
| customerservice@fdi.com | |
| Phone | 1-877-861-7246 |
| customerservice@fdi.com | |
| Phone | 1-877-861-7246 |
| customerservice@fdi.com | |
| Phone | 1-877-861-7246 |
| customerservice@fdi.com | |
| Phone | 1-877-861-7246 |
| customerservice@fdi.com | |
| Phone | 1-877-861-7246 |
| customerservice@fdi.com | |
| Phone | 1-877-861-7246 |
| customerservice@fdi.com | |
| Phone | 1-877-861-7246 |
| customerservice@fdi.com | |
| Phone | 1-877-861-7246 |
| customerservice@fdi.com | |
| Phone | 1-877-861-7246 |
| customerservice@fdi.com | |
| Phone | 1-877-861-7246 |
| customerservice@fdi.com | |
| Phone | 1-877-861-7246 |
| customerservice@fdi.com | |
| Phone | 1-877-861-7246 |
| customerservice@fdi.com | |
| Phone | 1-877-861-7246 |
| customerservice@fdi.com | |
| Phone | 1-877-861-7246 |
| customerservice@fdi.com | |
| Phone | 1-877-861-7246 |
| customerservice@fdi.com | |
| Phone | 1-877-861-7246 |
| customerservice@fdi.com | |
| Phone | 1-877-861-7246 |
| customerservice@fdi.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00869164000000 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- H060004
FDA Product Code
| OAW | Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic Mesothelioma |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-17 |
Devices Manufactured by Fujirebio Diagnostics, Inc.
| 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 |
| 00869164000000 - MESOMARK | 2018-07-06 |
| 00869164000017 - Lumipulse G ROMA | 2018-07-06 Software Disk |
| 00869164000024 - ROMA | 2018-07-06 ROMA (HE4 EIA + ARCHITECT CA125II) Software disk |
Trademark Results [MESOMARK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MESOMARK 78530279 3091521 Live/Registered |
Fujirebio Diagnostics, Inc. 2004-12-10 |
 MESOMARK 78421763 3276224 Live/Registered |
Fujirebio Diagnostics, Inc. 2004-05-19 |
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