AccessGUDID - DEVICE: IMMUNOSUPPRESSANTS QC 2 (B80002509000020)

GUDID

Device Identifier (DI) Information

Brand Name: IMMUNOSUPPRESSANTS QC 2
Version or Model: 025090-0002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IMMU 2 MAYO V2
Company Name: UTAK LABORATORIES, INC.

Primary DI Number: B80002509000020
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092519016 *Terms of Use

Device Description: IMMUNOSUPPRESSANTS QC 2

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?
60456	Multiple immunosuppressant therapeutic drug monitoring IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple immunosuppressant drugs which may include cyclosporin A (or cyclosporine), tacrolimus, sirolimus and/or everolimus, in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LAS	Drug Specific Control Materials

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 10 Milliliter

Device Record Status

Public Device Record Key: d59ba326-0fbf-4d6d-831f-24351a647496
Public Version Date: June 24, 2020
Public Version Number: 1
DI Record Publish Date: June 16, 2020