AccessGUDID - DEVICE: Emit Cyclosporine Sample (00869164000079)

GUDID

Device Identifier (DI) Information

Brand Name: Emit Cyclosporine Sample
Version or Model: 4008086
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FUJIREBIO DIAGNOSTICS, INC.

Primary DI Number: 00869164000079
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079291908 *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):	No
Over the Counter (OTC):	No
Kit:	No
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?
55441	Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement and therapeutic monitoring of the immunosuppressant drug cyclosporin A or cyclosporine in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MKW	Cyclosporine

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
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 100 tests per kit

Device Record Status

Public Device Record Key: 406450ef-1b82-4f7f-9c7a-13b90cdd970a
Public Version Date: December 14, 2023
Public Version Number: 1
DI Record Publish Date: December 06, 2023