AccessGUDID - DEVICE: MESOMARK (00869164000000)

GUDID

Device Identifier (DI) Information

Brand Name: MESOMARK
Version or Model: 801-905
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Fujirebio Diagnostics, Inc.

Primary DI Number: 00869164000000
Issuing Agency: GS1
Commercial Distribution End Date: August 01, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 048524263 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
54639	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAW	Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic Mesothelioma

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Handling Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Size Type = Tests Per Kit; Size Unit = 96; Unit of Measure = Tests

Device Record Status

Public Device Record Key: a0e596ca-1ec5-400a-870b-754a0d093c45
Public Version Date: September 22, 2023
Public Version Number: 4
DI Record Publish Date: September 17, 2014