AccessGUDID - DEVICE: Dako (05700572028383)

GUDID

Device Identifier (DI) Information

Brand Name: Dako
Version or Model: FR700
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dako Denmark A/S

Primary DI Number: 05700572028383
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305047466 *Terms of Use

Device Description: Monoclonal Mouse Anti-Human CD45/FITC, Clone T29/33 Monoclonal Mouse Anti-Human CD14/RPE, Clone TÜK4

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
CD45 leukocyte common antigen cell marker 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 CD45 leukocyte common antigen cell marker in a clinical specimen.
CD14 cell marker 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 CD14 cell marker in a clinical specimen.

FDA Product Code

[?]

Product Code	Product Code Name
GKZ	Counter, differential cell

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K964974	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 0.5 Milliliter

Device Record Status

Public Device Record Key: bab18e85-ffeb-4dcb-88f5-a054d2caf98f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016