AccessGUDID - DEVICE: CEDIA Cyclosporine-PLUS Assay (00884883011861)

GUDID

Device Identifier (DI) Information

Brand Name: CEDIA Cyclosporine-PLUS Assay
Version or Model: 10016283
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Microgenics Corporation

Primary DI Number: 00884883011861
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122153799 *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:	Yes
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?
55438	Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the immunosuppressant drug cyclosporin A or cyclosporine in a clinical specimen, using a fluorescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MKW	Cyclosporine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K023208	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a7657009-1dd8-405c-abe4-fe7e443d1fa2
Public Version Date: April 30, 2019
Public Version Number: 4
DI Record Publish Date: September 24, 2016