FDA.reportPublic FDA data

MESOMARK

Primary DI
00869164000000
Brand
MESOMARK
Company
Fujirebio Diagnostics, Inc.
Model
801-905
Published
2014-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OAWCancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic Mesothelioma

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OAWCancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic MesotheliomaUnknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H060004000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H060004000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869164000000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869164000000008691640000008691640000000869164000000

GMDN Terms#

Term, Definition table
TermDefinition
Mucin-like carcinoma-associated antigen (MCA) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of mucin-like carcinoma-associated antigen (MCA) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature20 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-861-7246customerservice@fdi.com

Regulatory Flags#

DUNS number
048524263
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00869164000086Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio CL00732024-11-04
00850212007041Beckman Coulter PK TP System Control SetPH35022016-09-16
00850212007058Beckman Coulter PK CMV-PA SYSTEM Control Set240226PA23022016-09-16
00869164000055Serodia TP-PA Kits2349522023-12-06
00869164000062Serodia TP-PA Kits2349762023-12-06
00869164000079Emit Cyclosporine Sample40080862023-12-06
00869164000048Lumipulse G B-Amyloid Ratio (1-42/1-40) Calculator ToolCL00122022-11-10
00850212007096Lumipulse G Wash Solution40082482017-10-06
00869164000017Lumipulse G ROMACL00042016-09-19
00869164000024ROMA404-10US2016-09-19
00850212007072Fertility Control 21301622020-12-07
00850212007089Vitamin D Control21301662020-07-14
00850212007003FITC Anti-Rabies Monoclonal Globulin800-0922016-09-16
00850212007010Serodia TP-PA16262016-09-16
00850212007027Serodia TP-PA16332016-09-16
00850212007034Vitamin D Control21301522016-09-16
00850212007065Syphilis Control21301702017-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04987270233436Lumipulse G Mesothelin CalibratorFUJIREBIO INC.OAW2023-02-01
04987270235157Lumipulse G Mesothelin Immunoreaction CartridgesFUJIREBIO INC.OAW2023-02-01