AccessGUDID - DEVICE: Dako (05700571105603)

GUDID

Device Identifier (DI) Information

Brand Name: Dako
Version or Model: IC004
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: AGILENT TECHNOLOGIES, INC.

Primary DI Number: 05700571105603
Issuing Agency: GS1
Commercial Distribution End Date: October 31, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 084963177 *Terms of Use

Device Description: DuoFLEX Cocktail Anti-AMACR Anti-Cytokeratin HMW Anti-Cytokeratin 5/6 Ready-to-Use (Link)

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?
57543	Multiple prostate cancer-associated marker IVD, antibody	Multiple immunoglobulins (antibody cocktail) capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of multiple markers potentially associated with prostate cancer in a clinical specimen. Examples of detectable markers include prostatic intraepithelial neoplasia markers (e.g., cytokeratin HMW), prostate specific antigen (PSA), alpha-methylacyl-CoA racemase (AMACR), and p63 tumour protein.	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
Total Volume: 6 Milliliter

Device Record Status

Public Device Record Key: 0286bb7d-ba76-4179-96f4-33a0ea7f4f87
Public Version Date: October 27, 2023
Public Version Number: 4
DI Record Publish Date: September 17, 2020