AccessGUDID - DEVICE: Lumipulse G CA 19-9-N Calibrators (04987270230664)

GUDID

Device Identifier (DI) Information

Brand Name: Lumipulse G CA 19-9-N Calibrators
Version or Model: 230664
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: FUJIREBIO INC.

Primary DI Number: 04987270230664
Issuing Agency: GS1
Commercial Distribution End Date: January 12, 2023
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?
38225	Cancer antigen 19-9 (CA19-9) IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of gastrointestinal and pancreatic cancer antigen 19-9 (CA19-9) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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 = Units per Kit; Units = 2; Unit of Measure = 3.0 mLs

Device Record Status

Public Device Record Key: b2f743af-1336-4600-9550-89d8272b73eb
Public Version Date: October 10, 2024
Public Version Number: 5
DI Record Publish Date: July 02, 2020