AccessGUDID - DEVICE: FLEX Mono Rb A-Hu Cyclin D1 Cl EP12 RTU (05700571106013)

GUDID

Device Identifier (DI) Information

Brand Name: FLEX Mono Rb A-Hu Cyclin D1 Cl EP12 RTU
Version or Model: IS083
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: AGILENT TECHNOLOGIES, INC.

Primary DI Number: 05700571106013
Issuing Agency: GS1
Commercial Distribution End Date: August 31, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 084963177 *Terms of Use

Device Description: FLEX Monoclonal Rabbit Anti-Human Cyclin D1 Clone EP12 Ready-to-Use (Dako Autostainer/ Autostainer Plus)

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?
57069	Cyclin D1 IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of cyclin D1 in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NJT	IMMUNOHISTOCHEMISTRY REAGENTS AND KITS

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
Device Size Text, specify: 20-30 Tests

Device Record Status

Public Device Record Key: 94dcadf0-ab96-4b27-95c5-50797d38e5d7
Public Version Date: September 04, 2023
Public Version Number: 3
DI Record Publish Date: September 17, 2020