AccessGUDID - DEVICE: Lumipulse G Mesothelin Immunoreaction Cartridges (04987270235157)

GUDID

Device Identifier (DI) Information

Brand Name: Lumipulse G Mesothelin Immunoreaction Cartridges
Version or Model: 235157
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FUJIREBIO INC.

Primary DI Number: 04987270235157
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 710873907 *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?
63473	Soluble mesothelin-related peptide (SMRP) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of soluble mesothelin-related peptide (SMRP) in a clinical specimen, using a chemiluminescent immunoassay method. It is typically used as a prognostic marker to monitor the progression or recurrence of mesothelioma.	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
Special Storage Condition, Specify: right side up with care; no vibration
Storage Environment Temperature: between 2 and 10 Degrees Celsius
Handling Environment Temperature: between 2 and 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Size Type = Tests Per kit; Size Unit = 42; Unit of Measure = Tests

Device Record Status

Public Device Record Key: 5ff2d4e6-34df-49f6-931e-fc33db9d7266
Public Version Date: October 10, 2024
Public Version Number: 7
DI Record Publish Date: February 01, 2023